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

Model Number M8007A

Device Problem Self-Activation or Keying (1557)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The customer reported that the alarms for pap/cvp turned off by themselves, also visible was the bell with "x" next to the parameter.No patient harm was reported.

Manufacturer Narrative

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

• Brand Name: MP70 INTELLIVUE PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEM; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: denyse murphy ; 3000 minuteman road; andover, MA 01810 ; 9786597844
• MDR Report Key: 3838903
• MDR Text Key: 4619732
• Report Number: 9610816-2014-00027
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M8007A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2010
• 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