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

Model Number M8007A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 01/06/2014

Event Type  Death  

Event Description

The customer stated that there was a pt incident (till this point unk incident) and a few days later, the pt died.Customer claims they are uncertain whether the device failed to alarm or not.

Manufacturer Narrative

(b)(4).A f/u report will be submitted upon completion of the investigation.

• Brand Name: MP70 INTELLIVUE PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: nancy ataide ; 3000 minuteman rd; andover, MA 01810 ; 9786597429
• MDR Report Key: 3624476
• MDR Text Key: 4132711
• Report Number: 9610816-2014-00010
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2014

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: M8007A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/10/2014
• Initial Date FDA Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: No
• 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