Events

Retiro De Equipo (Recall) de Device Recall P.R.O. Matt

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Joerns Healthcare.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    80113
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2033-2018
  • Fecha de inicio del evento
    2018-05-03
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164569
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Mattress, flotation therapy, non-powered - Product Code IKY
  • Causa
    Joerns healthcare has identified a potential issue with some of the p.R.O. matt and procair mattresses. for the identified serial number range of p.R.O. matt and procair mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.
  • Acción
    The firm initiated the recall by letter on 05/04/2018. The letter requested the consignee identify potentially affected mattresses and contact Joerns Healthcare directly to schedule on-site rework of the unit. Distributors were directed to provide the recall information to their accounts.

Device

Device Recall P.R.O. Matt
  • Modelo / Serial
    P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA;  Serial Numbers:  1000057154 1000057153  (b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3684NZBA;  Serial Numbers:  1000051430 1000051425 1000051366 1000051422 1000056411 1000058530 1000056414  (c) PROMATT PLUS W/SIDEWALLS, 42X80, MATERIAL NUMBER PMS4280NZBA;  Serial Numbers:  1000049130 1000054638 1000054639  (d) PROMATT PLUS 36IN MATRESS, MATERIAL NUMBER PMP3680NZBA;  Serial Numbers:  1000057195 1000055122 1000055401 1000057190 1000055328 1000054681 1000057193 1000057171 1000051436 1000055326 1000054386 1000054387 1000054385 1000051441 1000051432 1000051439 1000054936 1000054144 1000054935 1000054390 1000054368 1000051440 1000054932 1000055059 1000055134 1000055070 1000055058 1000055118 1000054872 1000055317 1000055130 1000055074 1000055313 1000055093 1000054906 1000055091 1000055132 1000055068 1000054926 1000054922 1000055065 1000054373 1000055062 1000055329 1000054140 1000054868 1000055319 1000054683 1000051437 1000055111 1000049127 1000054927 1000054380 1000054375 1000052270 1000054383 1000054940 1000053404 1000054143 1000054915 1000054917 1000054379 1000054389 1000054924 1000054941 1000055114 1000054378 1000055316 1000054377 1000055337 1000054933 1000051367 1000054371 1000054388 1000052267 1000054142 1000055332 1000057169 1000057860 1000054907  (e) PROMATT WITH SIDEWALLS ASSEMBLY, MATERIAL NUMBER PMS3680NZBA;  Serial Numbers:  PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA  (f) PROMATT PLUS 80IN MATRESS, STRETCH, MATERIAL NUMBER PMP3680SZBA;  Serial Numbers:  PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA  (g) PROMATT PLUS 42IN MATRESS, MATERIAL NUMBER PMP4280NZBA;  Serial Numbers:  PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA  (h) PROMATT PLUS 85cm MATRESS, DURATUB, MATERIAL NUMBER PMPE3480SZBADT;  Serial Numbers:  PMPE3480SZBADT PMPE3480SZBADT PMPE3480SZBADT
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of UK, Canada, Holland
  • Descripción del producto
    P.R.O. Matt: || (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA || (b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3684NZBA || (c) PROMATT PLUS W/SIDEWALLS, 42X80, MATERIAL NUMBER PMS4280NZBA || (d) PROMATT PLUS 36IN MATRESS, MATERIAL NUMBER PMP3680NZBA || (e) PROMATT WITH SIDEWALLS ASSEMBLY, MATERIAL NUMBER PMS3680NZBA || (f) PROMATT PLUS 80IN MATRESS, STRETCH, MATERIAL NUMBER PMP3680SZBA || (g) PROMATT PLUS 42IN MATRESS, MATERIAL NUMBER PMP4280NZBA || (h) PROMATT PLUS 85cm MATRESS, DURATUB, MATERIAL NUMBER PMPE3480SZBADT || Product Usage: || Non powered flotation therapy mattress. The device is intended to treat or prevent decubitus ulcers (bed sores).
  • Manufacturer
    Joerns Healthcare

Manufacturer

Joerns Healthcare
  • Dirección del fabricante
    Joerns Healthcare, 2100 Design Rd, Arlington TX 76014-4593
  • Source
    USFDA