MAUDE Adverse Event Report: O-TWO MEDICAL TECHNOLOGIES INC O-TWO MEDICAL TECHNOLOGIES INC; ADULT VENTILATION TIMER

Model Number 01BM1000

Device Problems Imprecision (1307); Device Operates Differently Than Expected (2913)

Patient Problems Hypoventilation (1916); Overdose (1988); Confusion/ Disorientation (2553)

Event Date 05/08/2015

Event Type  malfunction  

Event Description

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.

• Brand Name: O-TWO MEDICAL TECHNOLOGIES INC
• Type of Device: ADULT VENTILATION TIMER
• Manufacturer (Section D): O-TWO MEDICAL TECHNOLOGIES INC; 7575 kimbel st; mississauga, ontario L5S 1C8; CA L5S 1C8
• MDR Report Key: 4802252
• MDR Text Key: 5829417
• Report Number: 4802252
• Device Sequence Number: 1
• Product Code: BTM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01BM1000
• Other Device ID Number: WHD03OB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2015
• Distributor Facility Aware Date: 05/08/2015
• Event Location: Home
• Date Report to Manufacturer: 05/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 91