FDA Adverse Event Death Summary report: N

SHARPLAN

MDR report key: 7434 · Received February 8, 1994

Report

Report Number: 7434
Event Type: Death
Date Received: February 8, 1994
Date of Event: January 31, 1994
Report Date: February 8, 1994
Manufacturer: SHARPLAN LASERS, INC.
Product Code: GEX
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

THE PT WAS INTUBATED WITH AN ENDOTRACHEAL TUBE, SEDATED AND MAINTAINED ON MECHANICAL VENTILATION AFTER THE 11/1/93 INJURY. THE PT'S CONDITION REMAINED CRITICAL. HEALTH CARE TEAM EFFORTS WERE FOCUSED ON LIFE SUPPORT AND TREATMENT ALTERNATIVES. ON 1/28/94, THE PT'S TEMPERATURE WAS ELEVATED AND HIS CONDITION SHOWED SIGNS OF DETERIORATION. DIALYSIS WAS ATTEMPTED. ON 1/30/94, THE PT SUFFERED A CARDIOPULMONARY ARREST. THE PT WAS SUCCESSFULLY RESUSCITATED, BUT DESPITE ALL MEDICAL TREATMENT INTERVENTIONS, HE WAS UNABLE TO MAINTAIN HIS VITAL SIGNS AND EXPIRED 1/31/94.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-NOV-93. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SHARPLAN	LASER, SURGICAL, CARBON-DIOXIDE	GEX	SHARPLAN LASERS, INC.	1055	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	22 YR		Death