MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FETAL MONITOR

Model Number M1351A

Device Problem Device Alarm System (1012)

Patient Problem Death, Intrauterine Fetal (1855)

Event Date 08/01/2012

Event Type  Death  

Event Description

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.

Manufacturer Narrative

(b)(4).A follow up report will be submitted after philips obtains more info concerning this event.

• Brand Name: FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer Contact: denyse murphy ; 3000 minuteman road; andover, MA 01810 ; 9786597844
• MDR Report Key: 4332454
• MDR Text Key: 5146273
• Report Number: 9610816-2014-00305
• Device Sequence Number: 1
• Product Code: HFM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K921957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M1351A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/1995
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death