*

Report

• Report Number: 3030108
• Event Type: Malfunction
• Date Received: January 14, 2013
• Date of Event: November 19, 2012
• Report Date: January 14, 2013
• Manufacturer: ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
• Product Code: LWS
• Product Problem: Yes
• Report Source: User Facility report
• Reporter Location: RI, US

Narratives

Description of Event or Problem · 1

DURING SURGICAL PROCEDURE PATIENT CONDITION CHANGED NECESSITATING THE USE OF DEFIBRILLATION USING INTERNAL PADDLES. PADDLES WERE USED BUT THEY DID NOT DISCHARGE. A SECOND SET OF INTERNAL PADDLES WERE USED AND AGAIN FAILED TO DISCHARGE. BIOMEDICAL TECHNICIAN WAS CALLED TO THE ROOM, THE DEFIBRILLATOR WAS TESTED AND PASSED THE TEST. EXTERNAL PADS WERE APPLIED TO PATIENT EMERGENT AND SHOCK WAS SUCCESSFULLY DELIVERED. THE INTERNAL PADDLES WERE ISOLATED AND BAGGED FOR FURTHER TESTING AND INSPECTION. BIOMED HAS SINCE RETURNED THE INTERNAL PADDLES FOR REPROCESSING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
21870	*	DEFIBRILLATOR	LWS	ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS	*	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR

Terms

Patient problem · 1

• No Known Impact Or Consequence To Patient

Product problems · 1

• Failure to Discharge

Type of report · 1

• Initial submission