MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-06-18 for RESPIRONIC BIPAP MASK 1012624 manufactured by Philips/respironics.
[1405030]
A (b)(6) female with a medical history of copd, chf, sleep apnea and hypothyroidism was admitted on (b)(6) 2010, due to hypercapneic respiratory failure. The pt was ordered bipap therapy. The pt was level of treatment: dnr-a. On (b)(6) 2010, at approx 0615, the pt was found unresponsive and pulseless in her room. It was identified that the bipap oxygen tubing was disconnected from the bipap mask and the bipap device did not alarm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1734148 |
| MDR Report Key | 1734148 |
| Report Source | 99 |
| Date Received | 2010-06-18 |
| Date of Report | 2010-06-18 |
| Date of Event | 2010-06-15 |
| Date Facility Aware | 2010-06-15 |
| Report Date | 2010-06-18 |
| Date Reported to FDA | 2010-06-18 |
| Date Reported to Mfgr | 2010-06-18 |
| Date Added to Maude | 2010-06-25 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESPIRONIC BIPAP MASK |
| Generic Name | BIPAP MASK |
| Product Code | BYE |
| Date Received | 2010-06-18 |
| Model Number | 1012624 |
| Lot Number | APO90525 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS/RESPIRONICS |
| Manufacturer Address | ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-06-18 |