MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-20 for FISHER&PAYKEL HC407A * manufactured by *.
[19148954]
Rptr has obstructive sleep apnea and sleeps on a cpap respirator. At the beginning of the month, rptr received a new cpap mask, the fisher paykel flexifit 407. Rptr ordered it because they used two previous models of mask by this company and was very satisfied with them. Within a couple of days of using the mask rptr began to feel the way they did just before they were diagnosed with osa--like they were dying---totally lethargic, confused, starving for air, sleepy, and like they could barely drag self around. It took a couple of weeks of enduring this before rptr realized that the exhaust holes on the 407 are tiny and follow a curved path--and that condensation inside the mask was occluding the holes. Also, with water in the holes from the condensation, the mask whistles like a tea kettle. If rptr ordered that mask for elderly family member who has obstructive sleep apnea and congestive heart failure, rptr thinks it would have killed him. Rptr is younger and healthier and feels like it nearly killed her.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036959 |
| MDR Report Key | 755700 |
| Date Received | 2005-10-20 |
| Date of Report | 2005-10-19 |
| Date of Event | 2005-10-01 |
| Date Added to Maude | 2006-08-31 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FISHER&PAYKEL |
| Generic Name | CPAP MASK |
| Product Code | NMC |
| Date Received | 2005-10-20 |
| Model Number | HC407A |
| Catalog Number | * |
| Lot Number | 050627 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 743537 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2005-10-20 |