MAUDE Adverse Event Report: O-TWO MEDICAL TECHNOLOGIES, INC. O-TWO ADULT VENTILATION TIMER; TIMER, GENERAL LABORATORY

Model Number 01BM1000

Device Problems Imprecision (1307); Misassembled (1398); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Hyperventilation (1910); Hypoventilation (1916); Overdose (1988); Confusion/ Disorientation (2553)

Event Date 05/08/2015

Event Type  malfunction  

Event Description

(b)(6) ems reported the following device malfunction of o-two adult ventilation timer (p/n # 01bm1000): 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 breathe 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 breathe at a rate appropriate for adults.In this case the light was flashing at a rate consistent with a pediatric patient.There is the potential that an adult patient in cardiac arrest is ventilated at a faster rate than recommended, hyperventilating patients during arrest reduces the efficacy of compressions during cpr.The suspect sample was returned on 05/22/2015.

Manufacturer Narrative

(b)(4).

• Brand Name: O-TWO ADULT VENTILATION TIMER
• Type of Device: TIMER, GENERAL LABORATORY
• Manufacturer (Section D): O-TWO MEDICAL TECHNOLOGIES, INC.; 7575 kimbel st.; mississauga, ontario L5S 1C8; CA L5S 1C8
• Manufacturer Contact: david zhang ; 7575 kimbel st.; mississauga, ontario L5S 1-C8 ; CA L5S 1C8 ; 6779410
• MDR Report Key: 4852956
• MDR Text Key: 18035066
• Report Number: 9610861-2015-00001
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Model Number: 01BM1000
• Device Catalogue Number: 01BM1000
• Device Lot Number: 079810
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SMART BAG MO
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 91