FDA Adverse Event Malfunction Summary report: N

LIFE PAK 10

MDR report key: 3811 · Received March 18, 1993

Report

Report Number
3811
Event Type
Malfunction
Date Received
March 18, 1993
Date of Event
January 21, 1993
Manufacturer
PHYSIO CONTROL
Product Code
DRK
Product Problem
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

ON 1/22/93, WISHARD AMBULANCE CREW RESPONDED TO RUN 2956 N. MERIDIAN. 29/W/F C/O SOB. PATIENT HOOKED TO MONITOR WITH SVT NOTED. REMAINED IN SVT FOR 9 MIN., CONVERTED TO SR WITH RUN OF VT (MONITOR RAN OUT OF PAPER). MONITOR SHOWED V-FIB AND PT. WAS ALERT AND CONSCIOUS, AND WAS ADKED SEVERAL TIMES. MONITOR H & H 87439 ALONG WITH CTS CABLES & BATTERIES WERE TURNED INDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JAN-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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RECALLED BY MANUFACTURER/DISTRIBUTOR, DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LIFE PAK 10 DRK PHYSIO CONTROL 804200-14

Patients

Seq Age Sex Outcome Treatment
1 29 YR Other