MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 1997-01-03 for PARATREND 7 SENSOR MPS 7004 manufactured by Biomedical Sensors Ltd.
[40141]
Customer reported that during measurement. The ph reading showed 9. 99. No report of injury has been received.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9612233-1996-90009 |
MDR Report Key | 62362 |
Report Source | 01,08 |
Date Received | 1997-01-03 |
Date of Report | 1996-12-19 |
Date of Event | 1996-12-14 |
Date Mfgr Received | 1996-12-17 |
Device Manufacturer Date | 1995-12-01 |
Date Added to Maude | 1997-01-17 |
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 | 1997-01-03 |
Model Number | PARATREND 7 SENSOR |
Catalog Number | MPS 7004 |
Lot Number | 472 |
ID Number | * |
Device Expiration Date | 1996-11-01 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | * |
Device Eval'ed by Mfgr | N |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 62678 |
Manufacturer | BIOMEDICAL SENSORS LTD |
Manufacturer Address | GEORGE ST HIGH WYCOMBE BUCKS UK HPII 2XJ |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 1997-01-03 |