MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-21 for 7200 22125B N/A manufactured by Puritan Bennett.
[15615759]
A picker portable was used to take a chest x-ray. At that time the ventilator de-programmed and shut off. The ventilator was changed out and another x-ray of the chest was taken revealing a pneumothorax. A chest tube was put into place and another chest x-ray was takendevice not labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced:. Service provided by: distributor. Invalid data - service records availability. 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, performance tests performed. Results of evaluation: invalid data. Conclusion: invalid data, device failure indirectly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3560 |
| MDR Report Key | 3560 |
| Date Received | 1992-07-21 |
| Date of Report | 1992-06-18 |
| Date of Event | 1992-06-09 |
| Date Facility Aware | 1992-06-09 |
| Report Date | 1992-06-18 |
| Date Reported to FDA | 1992-06-18 |
| Date Reported to Mfgr | 1992-06-09 |
| Date Added to Maude | 1993-04-23 |
| 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 | 7200 |
| Generic Name | VENILATOR |
| Product Code | BZG |
| Date Received | 1992-07-21 |
| Model Number | 22125B |
| Catalog Number | N/A |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-NOV-90 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 3302 |
| Manufacturer | PURITAN BENNETT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-07-21 |