MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for FISHER & PAYKEL OPTIFLOW + manufactured by Fisher & Paykel Limited Healthcare.
[177675876]
Pt noted to be desatting and upon approaching pt, noted white corrugated nasal cannula portion of optiflow had torn off completely from blue corrugated tubing. Per rt she had another incident like this earlier in the week with the same issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092700 |
| MDR Report Key | 9659257 |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-27 |
| Date of Event | 2020-01-22 |
| Date Added to Maude | 2020-02-03 |
| 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 | FISHER & PAYKEL OPTIFLOW + |
| Generic Name | CANNULA, NASAL, OXYGEN |
| Product Code | CAT |
| Date Received | 2020-01-31 |
| Lot Number | 2100001426 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL LIMITED HEALTHCARE |
| Brand Name | FISHER & PAYKEL OPTIFLOW + |
| Generic Name | CANNULA, NASAL, OXYGEN |
| Product Code | CAT |
| Date Received | 2020-01-31 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL LIMITED HEALTHCARE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |