MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS V24/26 COMPONENT MONITORING SYSTEM

Model Number M1205A

Device Problem Device Alarm System (1012)

Patient Problem Death (1802)

Event Date 02/27/2014

Event Type  Death  

Event Description

The customer stated that the device did not alarm when the pt removed the ecg pads.The pt is deceased.

Manufacturer Narrative

(b)(4).A f/u report will be submitted after philips obtains more info concerning this event.

• Brand Name: V24/26 COMPONENT MONITORING SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer Contact: denyse murphy ; 3000 minutemann road; andover, MA 01810 ; 9786597844
• MDR Report Key: 3775664
• MDR Text Key: 4374253
• Report Number: 9610816-2014-00101
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K002758
• 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: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: M1205A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2001
• 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