FDA Adverse Event Death Summary report: N

GEM-STAT INSTRUMENT WITH GEM-STAT PAK CARTRIDGE

MDR report key: 4875 · Received July 21, 1992

Report

Report Number: 4875
Event Type: Death
Date Received: July 21, 1992
Date of Event: November 15, 1991
Report Date: July 20, 1992
Manufacturer: MILLINCKRODT SENSOR SYSTEMS, INC.
Product Code: DRY
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

INCONSISTENT COMPARISONS DONE, TEST RESULTS USED FOR INTERPRETATION OF BLOOD GASES DURING OPEN HEART SURGERY. PATIENT CODED AND DIEDINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. 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: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GEM-STAT INSTRUMENT WITH GEM-STAT PAK CARTRIDGE	BLOOD GAS/ELECTROLYTE MONITOR	DRY	MILLINCKRODT SENSOR SYSTEMS, INC.	1280	(CARTRIDGE) 1266-391

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death