MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-09 for 8400 ST VOLUME VENTILATOR manufactured by Bird Products.
[3462]
Ventilator stopped suddenly. Nurse gave manual breaths with ambu bag until backup ventilator was placed by respiratory therapistdevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-dec-92. Service provided by: other. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: performance tests performed. Results of evaluation: component failure, invalid data. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service, device temporarily removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5452 |
| MDR Report Key | 5452 |
| Date Received | 1993-04-09 |
| Date of Report | 1993-03-01 |
| Date of Event | 1993-01-26 |
| Report Date | 1993-03-01 |
| Date Reported to Mfgr | 1993-01-27 |
| Date Added to Maude | 1993-07-13 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 8400 ST VOLUME VENTILATOR |
| Generic Name | ADULT VOLUME VENTILATOR |
| Product Code | BYT |
| Date Received | 1993-04-09 |
| Model Number | 8400 ST |
| ID Number | #10 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 5148 |
| Manufacturer | BIRD PRODUCTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-04-09 |