CPAP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-04 for CPAP manufactured by Resmed Corp..

Event Text Entries

[182526135] On 3rd cpap and supplier. Prior was (b)(6) patient, which was horrific, and even dr stated all were terrible. Taken over by (b)(6) it has proven worse. Ship wrong supplies, do not follow up (even to dr's office) and no show on / scheduled appts. Told only 1 rep for entire region. Focus is on oxygen, not cpap/ which is potentially dangerous. Original cpap data never entered by rep excuse for wrong supplies. Still using original container and last mask for months. Can't seem to resolve no matter is tried. No accountability, or interest in correcting situation. Cpap as a whole (not the device) is a travesty and a disgrace. Only focus is where more money can be gained. Little or not interest in servicing or treating needs of pts. Promise home service but rarely provided. Inexcusable disregard for needs of pts, despite calls from dr's office staff to correct or change. Everyone admits it is a bad situation, but no one seems to know what to do, or what can be done about it. There doesn't seem to be any accountability or oversight with regard to this whole industry of alleged home care devices -- never was, nor seems to exist. Seems to go from bad to worse. Even where there is minimal human contact, there lacks any evidence of sharing of information nor even knowledge of others in same organization. No one follows up, nor seems to care. It is a disgraceful segment of the healthcare realm. Told mask was "nose pillow" when last cpap was received. Recent visit by rep claims -it is "full face mask" which is excuse for multiple wrong shipments received (unreturnable). Radically incompetent and dishonest with minimal service.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093531
MDR Report Key9793157
Date Received2020-03-04
Date of Report2020-02-29
Date Added to Maude2020-03-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameCPAP
Generic NameVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Product CodeBZD
Date Received2020-03-04
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerRESMED CORP.

Device Sequence Number: 2

Brand NameCPAP
Generic NameVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Product CodeBZD
Date Received2020-03-04
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerRESMED CORP.

Device Sequence Number: 3

Brand NameCPAP
Generic NameVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Product CodeBZD
Date Received2020-03-04
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0
ManufacturerRESMED CORP.


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-04

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