FDA Adverse Event Injury Summary report: N

VENTILATOR

MDR report key: 3642 · Received January 20, 1993

Report

Report Number: 3642
Event Type: Injury
Date Received: January 20, 1993
Date of Event: December 2, 1992
Report Date: December 9, 1992
Manufacturer: LIFECARE RESPIRATORY EQUIPMENT
Product Code: CBK
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

PATIENT COMPLAINED OF SHORTNESS OF BREATH WHILE ON VENTILATOR. VENTILATOR (9004125) CHECKED AND FOUND TO BE NOT FUNCTIONING. VENTILATOR REMOVED AND ANOTHER VENTILATOR (870417) APPLIED. WITHIN 30 MINUTES, THE NEW VENTILATOR BEGAN ALARMING. PATIENT WAS LETHARGIC AND HYPOTENSIVE. SECOND VENTILATOR WAS REPLACED. PATIENT WAS TRANSPORTED TO EMERGENCY DEPARTMENT PER PHYSICIAN ORDER. WAS EVALUATED AND RETURNED TO ECF. BOTH VENTILATORS WERE SENT TO DISTRIBUTOER FOR EVALUATION.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-FEB-92. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: MOTOR. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1		VENTILATOR	CBK	LIFECARE RESPIRATORY EQUIPMENT	PLV100

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Other