FDA Adverse Event Injury Summary report: N

ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION

MDR report key: 3492 · Received July 31, 1992

Report

Report Number
3492
Event Type
Injury
Date Received
July 31, 1992
Date of Event
June 10, 1992
Report Date
June 18, 1992
Manufacturer
VITAL SIGNS
Product Code
BSJ
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

THE BREATHING CIRCUIT WAS CHECKED PRIOR TO ANESTHESIA AND WAS PATENT. THE PATIENT WAS INTUBATED WITH FIBROPTIC SCOPE AND AFTER CONNECTION OF THE BREATHING CIRCUIT NO BREATH SOUNDS WERE HEARD. WITH MASK VENTILATION AND ENDOTUBE STILL IN PLACE SA02 ROSE FROM 50 TO 96. MASK VENTILATION WAS DIFFICULT. ETIDAL C02 SHOWED SMALL WAVES AND WAS RECALIBRATED, ANECTINE GIVEN; PATIENT REINTUBATED UNDER DIRECT VISION WITH LARGER #8 ET - NO VENT. MOUTH - ENDOTUBE; EMERGENT TRACH DONE. ET TUBE IN PLACE. AMBUBAG USED WITH INCREASE IN SA02 TO 100%. CIRCUIT RECHECKED, SMALL PIECE OF PLASTIC FROM FACE MASK BLOWN OUT OF PALL FILTER APPARENTLY FROM WRAPPER OF DISPOSABLE FACE MASK, BUT EXACT PIECE OF PLASTIC NOT FOUND. IT WAS OBSERVED TO COME OUT BY CRNADEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: STORAGE/SHIPMENT, OTHER. CONCLUSION: OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION BSJ VITAL SIGNS

Patients

Seq Age Sex Outcome Treatment
1 35 YR Required Intervention