MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-19 for FLEXIFIT 405 NASAL MASK HC405A * manufactured by Fisher & Paykel Healthcare.
[623842]
Elbow cracked on hc405 mask. Determined to be a tab style connector.
Patient Sequence No: 1, Text Type: D, B5
[7959993]
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 an redesigned connector ana is not subject to this recall.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611451-2007-00070 |
| MDR Report Key | 869832 |
| Date Received | 2007-03-19 |
| Date of Report | 2007-03-19 |
| Date of Event | 2007-02-20 |
| Date Mfgr Received | 2007-02-21 |
| Date Added to Maude | 2007-06-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JAMES THOMPSON, MGR |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE EAST TAMAKI |
| Manufacturer City | PANMURE, AUCKLAND 1741 |
| Manufacturer Country | NZ |
| Manufacturer Postal | 1741 |
| Manufacturer Phone | 5740100 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIFIT 405 NASAL MASK |
| Generic Name | NASAL CPAP MASK |
| Product Code | NMC |
| Date Received | 2007-03-19 |
| Model Number | HC405A |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 850981 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE |
| Manufacturer Address | * AUCKLAND NZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-19 |