MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-19 for TRANSDUCER PROTECTOR manufactured by Medisystems Corp..
[7554]
The dialysis machine had been experiencing frequent alarms, which eventually led to the system clotting off. The transducer protector was noted to have blood and when it was removed it was noted that blood was bubbling out of the transducer. This transducer is part of an on/off kit put together by healthcare suppliers. Technical support noted that blood had entered the internal transducer protector. Hosp has only used this product for approx 1 1/2 wks. (sample) (*)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000490 |
| MDR Report Key | 11068 |
| Date Received | 1994-01-19 |
| Date of Report | 1994-01-13 |
| Date of Event | 1994-01-10 |
| Date Added to Maude | 1994-01-27 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSDUCER PROTECTOR |
| Product Code | FIB |
| Date Received | 1994-01-19 |
| Lot Number | 6831 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11068 |
| Manufacturer | MEDISYSTEMS CORP. |
| Manufacturer Address | SEATTLE WA 98121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-01-19 |