MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-27 for TRANSDUCER FILTER 04-9307 manufactured by Gelman Sciences.
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Transducer protectable do not peal on machine causing venous chamber to continually rise up and wet the membrane causing irratic and irregular pressures and lmps. The unit is currenetly changing transducer 5-6 times per treatment x 15-20 treatments ebl 120ccdevice labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. 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: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1992-00091 |
| MDR Report Key | 1233 |
| Date Received | 1992-08-27 |
| Date of Report | 1992-08-27 |
| Date of Event | 1992-07-24 |
| Date Facility Aware | 1992-07-24 |
| Report Date | 1992-08-27 |
| Date Reported to FDA | 1992-08-27 |
| Date Reported to Mfgr | 1992-08-04 |
| Date Added to Maude | 1992-09-03 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | UNKNOWN |
| 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 | TRANSDUCER FILTER |
| Generic Name | TRANSDUCER FILTER |
| Product Code | FIB |
| Date Received | 1992-08-27 |
| Catalog Number | 04-9307 |
| Lot Number | 2211 |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1180 |
| Manufacturer | GELMAN SCIENCES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-08-27 |