MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-12-09 for WATER TRAP 5275P manufactured by Allegiance Healthcare Corp..
[154509]
Water trap release valve separated from the main body reservoir resulting in a loss of inhalation pressure on puritan bennett ventilator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-1998-00359 |
| MDR Report Key | 201078 |
| Report Source | 06 |
| Date Received | 1998-12-09 |
| Date of Report | 1998-12-09 |
| Date of Event | 1998-08-18 |
| Date Mfgr Received | 1998-08-26 |
| Device Manufacturer Date | 1998-04-01 |
| Date Added to Maude | 1998-12-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATER TRAP |
| Generic Name | WATER TRAP |
| Product Code | CBC |
| Date Received | 1998-12-09 |
| Model Number | 5275P |
| Catalog Number | 5275P |
| Lot Number | 804298 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 195322 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | WATER TRAP |
| Baseline Generic Name | WATER TRAP |
| Baseline Model No | 5275P |
| Baseline Catalog No | 5275P |
| Baseline ID | WATER TRAP |
| Baseline Device Family | WATER TRAP |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-12-09 |