FDA Adverse Event Malfunction Summary report: N

O-TWO MEDICAL TECHNOLOGIES INC

MDR report key: 4802252 · Received May 22, 2015

Report

Report Number
4802252
Event Type
Malfunction
Date Received
May 22, 2015
Date of Event
May 8, 2015
Report Date
May 20, 2015
Manufacturer
O-TWO MEDICAL TECHNOLOGIES INC
Product Code
BTM
Product Problem
Yes
Report Source
User Facility report
Reporter Location
TX, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

WHILE TREATING A PATIENT OF A SUSPECTED OPIOID OVERDOSE WITH RESPIRATORY DEPRESSION, THE O-TWO SMART BAG WITH AN ADULT VENTILATION TIMER LIGHT WAS USED TO BREATH FOR THE PATIENT. DURING THE COURSE OF CARE THE PARAMEDIC PROVIDING VENTILATIONS NOTICED THE ADULT VENTILATION TIMING LIGHT WAS BLINKING AT A HIGHER RATE THAN THAT STATED ON THE DEVICE. THEY DESCRIBED IT AS ABOUT 20-24 BLINKS/MINUTE. THE DEVICE IS LABELED F - 10/MIN. THIS TIMING LIGHT IS ACTIVATED TO GUIDE THE PERSON PROVIDING THE PATIENT VENTILATIONS TO BREATH AT A RATE APPROPRIATE FOR ADULTS. IN THIS CASE THE LIGHT WAS BLINKING AT A RATE CONSISTENT WITH A PEDIATRIC PATIENT. IN ADDITION, BECAUSE THE LIGHT IS ACTIVATED DURING CARDIAC ARREST THERE IS THE POTENTIAL THAT AN ADULT PATIENT IS VENTILATED AT A FASTER RATE THAN RECOMMENDED. THIS IS A LARGE RISK BECAUSE HYPERVENTILATING PATIENTS DURING ARREST REDUCES THE EFFICACY OF COMPRESSIONS DURING CPR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
337370 O-TWO MEDICAL TECHNOLOGIES INC ADULT VENTILATION TIMER BTM O-TWO MEDICAL TECHNOLOGIES INC 01BM1000 NA

Patients

Seq Age Sex Outcome Treatment
1 46 YR Other