MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for F&P ESON 2 NASAL MASK MEDIUM A FOR CPAP ESN2MA manufactured by Fisher & Paykel Healthcare Inc..
[174113165]
Hook and loop fastener on f&p eson 2 nasal mask headset ripped loose. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092069 |
| MDR Report Key | 9559232 |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-03 |
| Date of Event | 2020-01-01 |
| Date Added to Maude | 2020-01-07 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | F&P ESON 2 NASAL MASK MEDIUM A FOR CPAP |
| Generic Name | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
| Product Code | BZD |
| Date Received | 2020-01-06 |
| Model Number | ESN2MA |
| Catalog Number | ESN2MA |
| Lot Number | 2100898529 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-06 |