FDA Adverse Event Death Summary report: N

DEFIBRILLATOR

MDR report key: 7734 · Received February 4, 1994

Report

Report Number: 7734
Event Type: Death
Date Received: February 4, 1994
Date of Event: October 18, 1993
Report Date: October 29, 1993
Manufacturer: HEWLETT PACKARD
Product Code: MKJ
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

THE PATIENT WAS UNDERGOING ELECTIVE SURGERY FOR AN ABDOMINAL AORTIC ANEURYSM. THE ANESTHESIOLOGIST DETERMINED THERE WAS A MASSIVE PULMONARY EMBOLISM, THE PATIENT WAS CODED. THE DEFIBRILLATOR CHARDED UP PROPERLY BUT FAILED TO STAFF REVIEWED THE CASE ON 10-21-1993 AND DETERMINED THE DEFIBRILLATOR FAILURE DID NOT CONTRIBUTE TO THE CAUSE OF DEATH, NO AUTOPSY WAS NECESSARY DUE TO THE KNOWN DISEASE.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-APR-93. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DEFIBRILLATOR	DEFIBRILLATOR	MKJ	HEWLETT PACKARD	78660B	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Death