MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-11 for PB7200A manufactured by Puritan Bennett.
[20052121]
Ventilator was "blacked out", not operating and ready"error 1501" with no alarms. Patient may have been compromised. Service representative has been called in and is doing a diagnostic evaluation. Device not labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-apr-93. Service provided by: factory trained/authorized/owned service organization. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8184 |
| MDR Report Key | 8184 |
| Date Received | 1993-08-11 |
| Date of Report | 1993-06-04 |
| Date of Event | 1993-06-01 |
| Date Facility Aware | 1993-06-01 |
| Report Date | 1993-06-04 |
| Date Reported to FDA | 1993-06-04 |
| Date Reported to Mfgr | 1993-06-02 |
| Date Added to Maude | 1994-07-27 |
| 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 |
| Generic Name | POSITIVE PRESSURE VENTILATOR |
| Product Code | BYT |
| Date Received | 1993-08-11 |
| Model Number | PB7200A |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 7859 |
| Manufacturer | PURITAN BENNETT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-08-11 |