Alerta De Seguridad para S8 Continuous Positive Airway Pressure (CPAP) Unit

Safety alert

2007-04-25

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20070425.html

Recall of medical device for treatment of temporary stoppage of breathing during sleep (cpap machines) the department of health (dh) today (april 25) alerted the public, in particular, the medical community in hong kong, about a worldwide voluntary recall of a number of cpap machines (flow generators), a medical device for treating obstructive sleep apnea (temporary stoppage of breathing during sleep), due to a potential danger of short circuit in the power supply connector which may result in device failure or fire. the recall, announced by its manufacturer, resmed, involves about 300 000 generators called s8 continuous positive airway pressure (cpap) unit. about 360 of them were sold in hong kong. a dh spokesman said the department has alerted the hospital authority, the private hospitals, the nursing homes, and medical professional institutions of the recall today. he said that affected users using cpap units with supplemental oxygen should immediately stop using the device and contact resmed hong kong ltd. for a replacement of the affected parts. other affected users should follow the manufacturer's advice and contact resmed hong kong ltd. for equipment rectification. a hotline 2366 0707 has been set up by the company to answer enquiries during office hours (monday - friday: 10:00 am - 6:00 pm ; saturday: 10:00 am - 4:00 pm ). patients are reminded to be extra cautious in using the device and take the following safety measures: to make sure that the device is placed on a hard clean surface and that the area around the device is clear during use; and to discontinue use of the device if there are any signs of electrical failure such as intermittent power, cracking sounds, sparking or charred smell. according to resmed hong kong ltd, the company is notifying all affected patients/users to provide advice and for replacement of the device parts. according to the manufacturer, the potential for a short circuit in the power supply connector is less than 0.2%. in the seven cases reported worldwide, device failures have led to thermal damage to the device, with a remote potential to ignite material external to the device. there are no reports of significant property damage or patient injury arising from this issue. dh has not received any report of untoward incidents in hong kong arising from this issue. members of the public may visit http://www.Resmed.Com/en-us/s8program/s8program.Html for more information. this recall includes s8 cpap units falling within the following serial number ranges: (i) 20040285613 to 20060269563, (ii) 20060275728 to 20060276751, (iii) 20060277160 to 20060277415, (iv) 20060281672 to 20060281991, (v) 20060283424 to 20060283743, (vi) 20060284896 to 20060285445, (vii) 20060287568 to 20060290823, (viii) 20060292360 to 20060294694, (ix) 20060312361 to 20060312597, (x) 20060318692 to 20060319459, (xi) 20060325074 to 20060327794, (xii) 20060330588 to 20060331043. affected devices can be identified by the serial numbers on the bottom of each device. nds/wednesday, april 25, 2007.