FDA Adverse Event Death Summary report: N

TRACHEAL TUBE - MURPHY CUFFED - SIZE 6.0

MDR report key: 148 · Received January 28, 1992

Report

Report Number
148
Event Type
Death
Date Received
January 28, 1992
Date of Event
December 24, 1991
Report Date
January 6, 1992
Manufacturer
INTERTECH/OHIO, DIV. OF INTERTECH RESOURCES, INC.
Product Code
BSK
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

PATIENT SUFFERED NEAR DROWING. PATIENT WAS INTUBATED BY EMSA AT THE SCENE AND ENDOTRACHEAL TUBE REMAINED IN PLACE AS PATIENT WAS BROUGHT TO SAINT FRANCES HOSPITAL FOR FURTHER TREATMENT. PATIENT WAS REQUIRING HIGH FIO2 AND PEEP AROUND 12-14. PATIENT WAS RECEIVING BREATHING TREATMENT OF .5CC ALBUTEROL. AFTER TREATMENT WAS COMPLETED RESPIRATORY THERAPIST CONNECTED PATIENT BACK TO VENTILATOR. IT WAS DETECTED THAT PATIENT'S OXYGEN SATURATION LEVEL HAD DECREASED, PATIENT NOT RETURNING VOLUME TO VENTILATOR, NO CHEST MOVEMENTS. AUDIBLE LEAK DETECTED IN ENDOTRACHEAL TUBE. PATIENT REQUIRED REINTUBATION. CODE BLUE INITIATED. PATIENT EXPIRED. NO EVALUATION PERFORMED. ENDOTRACHEAL TUBE DISPOSED OF AT TIME OF PATIENT'S EXPIRATIONINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE DISCARDED, INVALID DATA. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TRACHEAL TUBE - MURPHY CUFFED - SIZE 6.0 BSK INTERTECH/OHIO, DIV. OF INTERTECH RESOURCES, INC. 225-6183-600 UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 16 YR Death