MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-30 for BIRD P7 SCANNER 9900 manufactured by Bird Products Corp..
[9575]
Pt was found in respiratory distress. Suction port on ventilator tubing was found open and monitor did not alarm. She was on cpap at the time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 10182 |
| MDR Report Key | 10182 |
| Date Received | 1993-08-30 |
| Date of Report | 1993-08-06 |
| Date of Event | 1993-07-04 |
| Date Facility Aware | 1993-07-04 |
| Report Date | 1993-08-06 |
| Date Reported to Mfgr | 1993-08-06 |
| Date Added to Maude | 1993-09-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIRD P7 SCANNER |
| Generic Name | MONITOR/ALARM |
| Product Code | CAP |
| Date Received | 1993-08-30 |
| Model Number | 9900 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10182 |
| Manufacturer | BIRD PRODUCTS CORP. |
| Manufacturer Address | 3101 E ALEJO RD PALM SPRINGS CA 922626267 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-08-30 |