FDA Adverse Event Malfunction Summary report: N

SHERIDAN

MDR report key: 3178 · Received July 13, 1992

Report

Report Number: 3178
Event Type: Malfunction
Date Received: July 13, 1992
Date of Event: March 5, 1992
Report Date: March 18, 1992
Manufacturer: SHERIDAN CATHETER CORP.
Product Code: LNZ
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

PATIENT INTUBATED BY EMS WHILE ENROUTE TO EMERGENCY ROOM. ADMITTED IN RESPIRATORY FAILURE, SEPSIS SECONDARY TO PNEUMONIA, HISTORY OF MULTIPLE SCLEROSIS. PHYSICIAN INITIALLY NOTED ET TUBE IN PLACE, CUFF FULLY INFLATED. SEVERAL HOURS LATER, PHYSICIAN INITIALLY NOTED ET TUBE CUFF WOULD NOT REMAIN INFLATED. PATIENT IMMEDIATELY RE-INTUBATED WITHOUT COMPLICATION. PATIENT EXPIRED DUE TO SEPSIS. PLEASE NOTE, ET TUBE SUPPLIED BY EMS. EMS NOTIFIED OF PROBLEM POST-INCIDENTDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT 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. 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, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SHERIDAN	ENDO-TRACHEAL TUBE W/CUFF	LNZ	SHERIDAN CATHETER CORP.	SIZE 7-1/2/	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR		Other