MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR

Model Number M8007A

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 01/23/2014

Event Type  Death  

Event Description

The customer reported that a pt died after being disconnected from the m8007a mp70 pt monitor for several minutes.The customer reported that the pt monitor was only issuing a technical alarm (inop).

Manufacturer Narrative

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

• Brand Name: MP70 INTELLIVUE PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: greg theokas ; 3000 minuteman rd; andover, MA 01810 ; 9786871501
• MDR Report Key: 3624478
• MDR Text Key: 4132712
• Report Number: 9610816-2014-00024
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/31/2014

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: Health Professional
• Device Model Number: M8007A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/31/2014
• Initial Date FDA Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2010
• 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