MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2007-06-01 for FLEXIFIT HC405 NASAL MASK HC405A manufactured by Fisher & Paykel Healthcare.
[638489]
Broken elbow tabs. Determined to be a tab style connector. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[7977615]
Method: device not available. Results: we became aware that a connector component used in a previous version of its cpap mask may fail prematurely if improperly cleaned. Plastic tabs incorporated into the connector components of these cpap masks may break off if they are not cleaned in accordance with our instructions for use. Conclusion: fisher & paykel healthcare is currently conducting a retail level recall on all tab designed connectors for cpap masks. We are currently awaiting classification of the fisher & paykel healthcare cpap mask and connectors recall from fda. All product manufactured since april 2006 features a redesigned connector and is not subject to this recall.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611451-2007-00189 |
| MDR Report Key | 858203 |
| Report Source | 05,08 |
| Date Received | 2007-06-01 |
| Date of Report | 2007-05-18 |
| Date of Event | 2007-05-18 |
| Date Mfgr Received | 2007-03-25 |
| Date Added to Maude | 2007-07-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TINA MASON, ENGINEER |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE |
| Manufacturer City | EAST TAMAKI, PANMURE AUCKLAND 1741 |
| Manufacturer Country | NZ |
| Manufacturer Postal | 1741 |
| Manufacturer Phone | 5740100 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIFIT HC405 NASAL MASK |
| Product Code | NMC |
| Date Received | 2007-06-01 |
| Model Number | HC405A |
| Catalog Number | HC405A |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 859117 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE |
| Manufacturer Address | AUCKLAND NZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-01 |