MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-12-04 for FETAL MONITOR M1351A manufactured by Philips Medical Systems.
[5146273]
The customer called philips on (b)(6) 2014 in order to know if it's mandatory to have alarms on a fetal monitor because of a investigation related to a death which occurred in (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5
[12641419]
(b)(4). A follow up report will be submitted after philips obtains more info concerning this event.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 9610816-2014-00305 |
MDR Report Key | 4332454 |
Report Source | 01,06 |
Date Received | 2014-12-04 |
Date of Report | 2014-04-04 |
Date of Event | 2012-08-01 |
Date Mfgr Received | 2014-04-04 |
Device Manufacturer Date | 1995-04-01 |
Date Added to Maude | 2014-12-17 |
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 | 3 |
Health Professional | 0 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | DENYSE MURPHY |
Manufacturer Street | 3000 MINUTEMAN ROAD |
Manufacturer City | ANDOVER MA 01810 |
Manufacturer Country | US |
Manufacturer Postal | 01810 |
Manufacturer Phone | 9786597844 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | FETAL MONITOR |
Product Code | HFM |
Date Received | 2014-12-04 |
Model Number | M1351A |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | PHILIPS MEDICAL SYSTEMS |
Manufacturer Address | HEWLETT-PACKARD STR.2 BOEBLINGEN 71034 GM 71034 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Death | 2014-12-04 |