FDA Adverse Event Malfunction Summary report: N

BIO-MED DEVICES, INC.

MDR report key: 25134913 · Received May 11, 2026

Report

Report Number
25134913
Event Type
Malfunction
Date Received
May 11, 2026
Date of Event
March 10, 2024
Report Date
April 28, 2026
Manufacturer
BIO-MED DEVICES, INC.
Product Code
CBK
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CT
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

S [SITUATION]: CALLED TO DR [DELIVERY ROOM] FOR "ASSISTANCE NEEDED" FOR FULL TERM BABY WITH A SLOW START. B [BACKGROUND]: FULL TERM BABY WITH POOR RESPIRATORY EFFORT REQUIRING PPV [POSITIVE PRESSURE VENTILATION], CPAP [CONTINUOUS POSITIVE AIRWAY PRESSURE] AND OXYGEN A [ASSESSMENT]: PATIENT RESUSCITATED INITIALLY WITH PPV VIA MASK AND T-PIECE RESUSCITATOR USING 60-100% OXYGEN TO ACHIEVE TARGET SATS. ONCE THE PATIENT BEGAN BREATHING PROVIDER SWITCHED TO CPAP VIA MASK AND TPR [TEMPERATURE, PULSE, AND RESPIRATION]. AT THIS TIME PATIENT REQUIRED 100% OXYGEN TO MAINTAIN TARGET SAT. I CONVERTED PATIENT TO TRANSPORT VENT (TV100 #7, ENGINEERING # [REDACTED]) WITH SETTINGS OF CPAP 7 100% O2 VIA NASAL MASK. PATIENT DESATURATED TO 59% ON THE TRANSPORT VENT. PATIENT HAD FAIR AIR ENTRY BILAT AND THE MASK HAD A GOOD SEAL. WHEN I WENT TO TROUBLESHOOT THE VENTILATOR, I FOUND THAT ALTHOUGH THE VENT WAS SET TO DELIVER 100% THE INHALED GAS WAS ANALYZED AT 21%. WE IMMEDIATELY REMOVED THE PATIENT FROM THE TRANSPORT VENT AND PLACED THEM BACK ON THE TPR WITH RETURN OF OXYGEN SATURATION TO 96%. R: TV 100 VENTILATOR PULLED FROM SERVICE AND IS IN THE RESPIRATORY CARE OFFICE FOR FURTHER EVALUATION. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
510640 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

Patients

Seq Age Sex Outcome Treatment
1