MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 1996-05-09 for PARATREND 7 SENSOR MPS7004 manufactured by Biomedical Sensors Ltd.
[20197875]
After four hours of monitoring the temperature reading went to zero. No report of injury has been rec'd.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9612233-1996-09004 |
MDR Report Key | 40084 |
Report Source | 01,08 |
Date Received | 1996-05-09 |
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 MONTURING SENSOR |
Product Code | CCC |
Date Received | 1996-05-09 |
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 | 41206 |
Manufacturer | BIOMEDICAL SENSORS LTD |
Manufacturer Address | HIGH WYCOMBE BUCKS UK |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1996-05-09 |