MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-21 for BEAR BEAR 3 NA manufactured by Bear Medical Systems Inc..
[16029126]
On 2/17/94 we learned from the hospital that a loud pop and then hissing sound was heard from the ventilator when it was being used on patient. The hospital told us that the patient was "bagged" and placed on another ventilator, and the patient was not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17354 |
| MDR Report Key | 17354 |
| Date Received | 1994-07-21 |
| Date of Report | 1994-03-03 |
| Date of Event | 1994-02-17 |
| Date Added to Maude | 1994-11-02 |
| 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 | BEAR |
| Generic Name | VENTILATOR |
| Product Code | CBP |
| Date Received | 1994-07-21 |
| Model Number | BEAR 3 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17283 |
| Manufacturer | BEAR MEDICAL SYSTEMS INC. |
| Manufacturer Address | 2085 RUSTIN AVENUE RIVERSIDE CA 925072437 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-21 |