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 Type  Death  

Event Description

The customer reported that the monitor was missing asystole alarm and that resuscitation of pt was necessary.The resuscitation was not successful.There was no delay with the resuscitation as there was nursing staff in the room and they monitored the status of the pt.According to the customer, the pt would have died even if the monitor's alert message had worked correctly.

Manufacturer Narrative

(b)(4).A follow up report will be submitted upon completion of the investigation.

• Brand Name: V24/26 COMPONENT MONITORING SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer Contact: kelly rector ; 3000 minuteman road; andover, MA 01810 ; 9786592590
• MDR Report Key: 3873820
• MDR Text Key: 4566054
• Report Number: 9610816-2014-00131
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/07/2014

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: 05/07/2014
• Initial Date FDA Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/1996
• 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