FDA Adverse Event Malfunction Summary report: N

INTELLIVUE MP2

MDR report key: 1812720 · Received August 17, 2010

Report

Report Number: 9610816-2010-00316
Event Type: Malfunction
Date Received: August 17, 2010
Report Date: August 5, 2010
Manufacturer: PHILIPS MEDICAL SYSTEMS
Product Code: MHX
PMA / PMN Number: K040357
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE CUSTOMER REPORTED THAT THEY HAD A SPEAKER MALFUNCTION. THE AVAILABLE INFORMATION DOES NOT INDICATE IF THERE WAS AN INOP OR IF THERE WAS ANY LOSS OF AUDIBLE FUNCTION. AS THE CUSTOMER HAS APPARENTLY RECOGNIZED THE SPEAKER FAILURE, AND AS NO PATIENT ADVERSE EVENT/ADVERSE PATIENT IMPACT WAS REPORTED TO HAVE RESULTED FROM THIS ISSUE, IT IS CONSIDERED THAT THE ISSUE WAS IMMEDIATELY OBVIOUS TO THE USER. GENERALLY, PATIENT ALARMS & TECHNICAL INOPS WILL CONTINUE TO BE ANNUNCIATED AT THE CENTRAL STATION (IF NETWORKED). IN AN ABUNDANCE OF CAUTION WE WILL REPORT LOSS OF AUDIO EVEN THOUGH A VISUAL WARNING IS PROVIDED AND PRODUCT LABELING DESCRIBES PERSONAL SURVEILLANCE. THE INTENTION ON MONITORING WOULD BE IN CLOSE PERSONAL OBSERVATION AS SPECIFIED IN THE PRODUCT LABELING. THIS WOULD ALERT THE USER TO A POSSIBLE DEVICE ISSUE TO TROUBLESHOOT THE DEVICE OR IMPLEMENT ALTERNATIVE MONITORING PER HOSPITAL PROTOCOL, AND/OR TO TROUBLESHOOT THE MONITOR. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THEY HAD A SPEAKER MALFUNCTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INTELLIVUE MP2		MHX	PHILIPS MEDICAL SYSTEMS	M8102A

Patients

Seq	Age	Sex	Outcome	Treatment
1