FDA Adverse Event Malfunction Summary report: N

PHILIPS HIGH END EXTERNAL SERVER

MDR report key: 1923885 · Received December 9, 2010

Report

Report Number: 9610816-2010-00762
Event Type: Malfunction
Date Received: December 9, 2010
Report Date: November 17, 2010
Manufacturer: PHILIPS MEDICAL SYSTEMS
Product Code: MHX
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4): THE CUSTOMER REPORTED THAT THEY WERE NOT HEARING ALERTS. BASED ON THE AVAILABLE INFO, A PHILIPS RESPONSE CENTER ENGINEER (RCE) DETERMINED THAT THERE WAS NO DEVICE MALFUNCTION BUT A LINE FOR OUTPUT TO THE SPEAKER WAS NOT CONNECTED CORRECTLY AFTER A RECENT UPGRADE. THE RCE INSTRUCTED THE CUSTOMER TO PLUG THE AMPLIFIER INTO A DIFFERENT CONNECTION AND CONFIRMED THAT THE SPEAKERS WERE THEN WORKING. IN ABUNDANCE OF CAUTION, WE ARE REPORTING THIS ISSUE AS IF THIS ISSUE COULD LEAD TO A POTENTIAL HEALTH RISK BECAUSE WE HAVE NOT YET DETERMINED THE PROVIDER OF THE UPGRADE SERVICING. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO 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 WERE NOT HEARING ALERTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PHILIPS HIGH END EXTERNAL SERVER		MHX	PHILIPS MEDICAL SYSTEMS	M1396D

Patients

Seq	Age	Sex	Outcome	Treatment
1