Events

Retiro De Equipo (Recall) de Device Recall Thumper Cardiopulmonary Resuscitator

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 Michigan Instruments, Inc..

¿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
    79764
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1632-2018
  • Fecha de inicio del evento
    2018-02-13
  • 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=163268
  • 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
    Compressor, cardiac, external - Product Code DRM
  • Causa
    A performance issue with the chest depth needle valve (cdnv) may arise where turning the knob will not deliver any compression depth to the piston during the first 5 revolutions of the knob.The last ¿ to ¿ revolution of the knob could deliver a full 8cm of compression.
  • Acción
    The customer was notified via email on 2/13/18. The customer has been instructed to identify the location of the affected units (if distributed, make arrangements to have unit returned for service), perform the CDNV replacement (instructions will be provided), and test the device to the Final Test Procedure (TS190). The customer should also record on the provided spreadsheet the SN of the CDNV replaced in the CCV device, date of replacement. A column is provided to check-off indicating the device was tested and accepted to the Final Test Procedure (TS190). Return the completed spreadsheet and the CDNVs that were replaced for evaluation.

Device

Device Recall Thumper Cardiopulmonary Resuscitator
  • Modelo / Serial
    CDNV - SN Installed In - Mfr Date 5519 CCV-2181 09/17 5518 CCV-2182 09/17 5516 CCV-2183 09/17 5517 CCV-2184 09/17 5522 CCV-2196 09/17 5531 CCV-2200 12/17 5533 CCV-2201 12/17 5538 CCV-2202 12/17 5524 CCV-2203 12/17 5523 CCV-2204 12/17 5526 CCV-2205 12/17 5528 CCV-2206 12/17 5529 CCV-2208 12/17 5535 CCV-2209 12/17 5530 CCV-2210 12/17 5534 CCV-2211 12/17 5539 CCV-2212 12/17 5520 CCV-2213 12/17 5532 CCV-2214 12/17 5525 CCV-2215 12/17 5536 CCV-2216 12/17 5537 CCV-2217 12/17 5521 CCV-2218 12/17 5527 CCV-2219 12/17 5541 CCV-2220 01/18 5550 CCV-2221 01/18 5546 CCV-2222 01/18 5544 CCV-2223 01/18 5543 CCV-2224 01/18 5542 CCV-2225 01/18 5553 CCV-2226 01/18 5547 CCV-2228 01/18 5549 CCV-2229 01/18 5548 CCV-2230 01/18 5545 CCV-2231 01/18 5540 CCV-2232 01/18 5555 CCV-2233 01/18 5554 CCV-2237 01/18
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to China.
  • Descripción del producto
    Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 || Product Usage: || The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
  • Manufacturer
    Michigan Instruments, Inc.

Manufacturer

Michigan Instruments, Inc.
  • Dirección del fabricante
    Michigan Instruments, Inc., 4717 Talon Ct SE, Grand Rapids MI 49512-5408
  • Empresa matriz del fabricante (2017)
    Michigan Instruments Inc
  • Source
    USFDA