MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-22 for RESPRONICS manufactured by Respironics.
[825000]
While traveling with a respronics "comfort jell series" mask used with a cpap machine for the treatment of obstructive sleep apnea, one of the "j" shaped ball hooks on the mask was crushed when my carry-on bag was "gate checked" by the airline. The crush made the mask unusable. This is a poor design.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5006035 |
| MDR Report Key | 1019991 |
| Date Received | 2008-03-22 |
| Date of Report | 2008-02-28 |
| Date of Event | 2007-10-09 |
| Date Added to Maude | 2008-04-03 |
| 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 |
| 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 | RESPRONICS |
| Generic Name | COMFORT JELL SERIES NASAL MASK |
| Product Code | NMC |
| Date Received | 2008-03-22 |
| Operator | OTHER |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 988959 |
| Manufacturer | RESPIRONICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-03-22 |