MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for BIPAP MACHINE 405692610 manufactured by Philips Respironics / Respironics, Inc..
[175666126]
Respiration therapist walked into the pt's room and noticed bipap touch screen had malfunctioned and nothing could be adjusted. He was called because alarms were going off on machine and would not shut off. He was told by nurse that pt was not doing well with oxygen, hr and noticed she had agonal breathing staff quickly started bagging pt and called equipment tech to come and swap out the bipap for a new one and then placed pt back on new machine and she quickly got back to her baseline. The pt was last checked before the event, and the bipap machine was operating properly. At the time of the event, the bipap machine was changed out and the pt was transferred to the icu. Later that day the bipap settings were documented back to the baseline setting prior to the event. The bipap machine was removed from service, red tagged, and secured. It was later interrogated and required servicing. It has since been returned back to service. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092228 |
| MDR Report Key | 9591490 |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-11-20 |
| Date Added to Maude | 2020-01-15 |
| 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 | BIPAP MACHINE |
| Generic Name | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
| Product Code | BZD |
| Date Received | 2020-01-14 |
| Model Number | 405692610 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS RESPIRONICS / RESPIRONICS, INC. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-14 |