FDA Adverse Event
Death
Summary report: N
FETAL MONITOR
MDR report key: 4332454
·
Received December 4, 2014
Report
- Report Number
- 9610816-2014-00305
- Event Type
- Death
- Date Received
- December 4, 2014
- Date of Event
- August 1, 2012
- Report Date
- April 4, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- HFM
- PMA / PMN Number
- K921957
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO CONCERNING THIS EVENT.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 783022 | FETAL MONITOR | MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC) | HFM | PHILIPS MEDICAL SYSTEMS | M1351A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |