RESMED S8 ESCAPE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-13 for RESMED S8 ESCAPE manufactured by Resmed.

Event Text Entries

[679341] I am writing because of lack of response by resmed, the company who supplies s8 flow generator devices for people that have respiratory problems. In my case sleep apneia. After receiving their "recall" letter which advises that my s8 escape device is susceptible to fatigue and failure including electrical failure, i. E. Fire. I have repeatedly tried contacting them to get a replacement unit. I have left messages with their recall people, but seem to get a round around. The latest call resulted in the representative saying that my issue will be forward to her supervisor and that within 24 hrs, they will contact me with a scheduled date for replacement. This was the same thing told to me on 08/2007. I understand that a recall can cause delay because of the shear numbers, but i don't believe this is the case for this product as not all devices are part of the recall. I request your assistance in obtaining this device so that i can be able to sleep without waking up choking. Dates of use: 2005 - 2007. Diagnosis or reason for use: sleep apneia - choking or stop breathing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5003406
MDR Report Key897547
Date Received2007-08-13
Date of Report2007-08-13
Date of Event2007-05-20
Date Added to Maude2007-08-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameRESMED S8 ESCAPE
Generic NameS8 FLOW GENERATOR DEVICE
Product CodeNHJ
Date Received2007-08-13
Model NumberS8 ESCAPE
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key876697
ManufacturerRESMED


Patients

Patient NumberTreatmentOutcomeDate
10 2007-08-13

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