MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for OPTIFLOW manufactured by Fisher & Paykel Healthcare, Inc..
[177602392]
Torn optiflow nasal cannula. Patient desaturates when leak occurs. Returns to baseline with new equipment that is intact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9665129 |
| MDR Report Key | 9665129 |
| Date Received | 2020-02-04 |
| Date of Report | 2019-12-11 |
| Date of Event | 2019-08-20 |
| Report Date | 2019-12-11 |
| Date Reported to FDA | 2019-12-11 |
| Date Reported to Mfgr | 2020-02-04 |
| Date Added to Maude | 2020-02-04 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | OPTIFLOW |
| Generic Name | CANNULA, NASAL, OXYGEN |
| Product Code | CAT |
| Date Received | 2020-02-04 |
| Lot Number | 2100725276 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE, INC. |
| Manufacturer Address | 173 TECHNOLOGY DR IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-04 |