MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-09 for SIMS 002566 manufactured by Sims Portex, Inc..
[92399]
The rptr relates that the following scenario has occurred twice. While moving a pt on a volume ventilator, the drain valve opened. The open valve caused a rapid decrease in circuit pressure since the air was exiting through the open valve, therefore the pt was not being ventilated. The problem was corrected with no harm to the pt. The rptr feels the drain valves open easily which leads to accidental opening. He states the water traps came from separate lots.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012960 |
| MDR Report Key | 147797 |
| Date Received | 1998-02-09 |
| Date of Report | 1998-02-09 |
| Date of Event | 1997-12-01 |
| Date Added to Maude | 1998-02-11 |
| 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 | 0 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMS |
| Generic Name | WATER TRAP WITH DRAIN VALVE |
| Product Code | BYH |
| Date Received | 1998-02-09 |
| Model Number | 002566 |
| Catalog Number | 002566 |
| Lot Number | 7E0252 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 144021 |
| Manufacturer | SIMS PORTEX, INC. |
| Manufacturer Address | 5100 TICE CT. FT. MYERS FL 33905 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-02-09 |