MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2007-04-05 for HC431NIV * manufactured by Fisher & Paykel Healthcare, Ltd..
[19489244]
Patient experienced skin redness and burning reaction on facial area, after using a re-processed full face niv (non-invasive ventilator) mask. No permanent injury, no medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
[19638428]
The flexifit hc431niv full face mask was re-processed using a chemical disinfectant (lysetol af2%) not recommended in user instructions and therefore, not validated for use on fisher & paykel healthcare masks. Please refer to current revision of european user instructions enclosed for details on approved multi-patient cleaning techniques for hc431niv masks. Hospital admitted that they used an un-approved cleaning disinfectant to clean mask prior to use on patient and stated that the patient skin reaction was potentially as a result of over exposure to disinfectant during cleaning. The patient was said to have sensitive skin. Please note-hc431niv is not currently available, however, all fisher & paykel healthcare cpap masks are of similar design to the niv range and are also validated for re-use according to similar disinfection techniques.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611451-2007-00031 |
| MDR Report Key | 834606 |
| Report Source | 01,05,06 |
| Date Received | 2007-04-05 |
| Date of Report | 2007-02-15 |
| Date Mfgr Received | 2007-02-08 |
| Date Added to Maude | 2007-04-06 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MISS JULIE COFORTH |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HC431NIV |
| Generic Name | FLEXIFIT HC431NIV FULL FACE MASK |
| Product Code | NMC |
| Date Received | 2007-04-05 |
| Model Number | HC431NIV |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 821918 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE, LTD. |
| Manufacturer Address | * AUCKLAND NZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-05 |