MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-05-15 for RESPIRONICS 1009040 manufactured by .
[838482]
Vendor of equipment was telling various info about the respironics comfortgel mask regarding mfr's defects - clips that hold strap constantly fail and make mask unusable. The vendor reluctantly replaced the defective mask. We were also told that it would not be covered by insurance and later told, it would be after the defect was known. The vendor apria healthcare is not responding correctly to a 'known' defect and several reps from apria later denied there was a problem with the mask. After research on the fda site, we found that respironics has had some problems related to this mask in the past this seems to be a new problem and is not being caught by the plant that makes them in another country, or the receiving qc dept. That handles incoming products. While this is not a life threatening situation, there seems to be a possibility that qc is not following design and material requirements given by the fda for such medical equipment. Diagnosis or reason for use: sleep apnea.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5006932 |
| MDR Report Key | 1047190 |
| Date Received | 2008-05-15 |
| Date of Report | 2008-05-15 |
| Date of Event | 2008-05-15 |
| Date Added to Maude | 2008-05-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESPIRONICS |
| Generic Name | COMFORTGEL MASK |
| Product Code | NMC |
| Date Received | 2008-05-15 |
| Model Number | 1009040 |
| Lot Number | AP.071017 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1016076 |
| Manufacturer Address | 1001 MURRAY RIDGE LANE MURRYSVILLE PA 15668 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-15 |