MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-09 for PARATREND 7 SENSOR MPS7004 manufactured by Biomedical Sensors Ltd.
[22067]
Prior to using the device the sensor became. "kinked" and could not be used. On investigation of this issue by the mfr, it was identified that the sensor had been damaged in a way consistent with the user not handling the device in accordance with labelled instructions. The problem was considered to be user error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612233-1996-09003 |
| MDR Report Key | 40088 |
| Date Received | 1996-05-09 |
| Date of Event | 1996-01-01 |
| Device Manufacturer Date | 1996-02-01 |
| Date Added to Maude | 1996-10-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARATREND 7 SENSOR |
| Generic Name | BLOOD GAS MONITORING SENSOR |
| Product Code | CCC |
| Date Received | 1996-05-09 |
| Model Number | MPS7004 |
| Catalog Number | MPS7004 |
| Lot Number | 477 |
| ID Number | NA |
| Device Expiration Date | 1997-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 41210 |
| Manufacturer | BIOMEDICAL SENSORS LTD |
| Manufacturer Address | GEORGE ST HIGH WYCOMBE * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-05-09 |