R SERIES DEFIBRILLATOR

Report

• Report Number: 1220908-2010-01920
• Event Type: Malfunction
• Date Received: July 22, 2010
• Report Date: July 6, 2010
• Manufacturer: ZOLL MEDICAL CORPORATION
• Product Code: MKJ
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVAL, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

Description of Event or Problem · 1

COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	R SERIES DEFIBRILLATOR	R SERIES DEFIBRILLATOR	MKJ	ZOLL MEDICAL CORPORATION	R SERIES	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA

Terms

Patient problem · 1

• No Patient Involvement

Product problems · 1

• Failure to Power Up

Source type · 2

• Foreign
• Other

Type of report · 1

• Initial submission