MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 1996-09-09 for PARATREND 7 SENSOR MPS7004 manufactured by Biomedical Sensors Ltd.
[27951]
Customer has reported anomalous readings. No report of injury has been rec'd.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9612233-1996-09002 |
MDR Report Key | 40094 |
Report Source | 01,06 |
Date Received | 1996-09-09 |
Date of Event | 1996-07-31 |
Date Mfgr Received | 1996-08-09 |
Device Manufacturer Date | 1996-04-01 |
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 | 1996-09-09 |
Model Number | MPS7004 |
Catalog Number | MPS7004 |
Lot Number | 544 |
ID Number | NA |
Device Expiration Date | 1997-03-01 |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
Device Age | * |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 41215 |
Manufacturer | BIOMEDICAL SENSORS LTD |
Manufacturer Address | GEORGE ST HIGH WYCOMBE BUCKS UK |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 1996-09-09 |