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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO POWER DRIVER; CONNECTOR, AIRWAY (EXTENSION)
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TELEFLEX MEDICAL EZ-IO POWER DRIVER; CONNECTOR, AIRWAY (EXTENSION) Back to Search Results
Catalog Number 9058
Device Problem Intermittent Loss of Power (4016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/26/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the driver appeared to run out of battery however the indicator light had not turned red prior to this.It was green prior to the driver stopping working.There was no patient injury.
 
Manufacturer Narrative
(b)(4).The dhr file is not available for review in the us.Ez-io driver 9058 (sn (b)(4)) was never returned to teleflex for investigation purposes.The root cause cannot be established.The complaint cannot be confirmed.Several sections of the ifu will be referenced as part of this investigation report.The ifu states, "as with any emergency medical device carrying a backup is strongly advised protocol", "ez-io power driver led with blink red when the trigger is activated and has only 10% of battery life remaining", and "purchase and replace the ez-io power driver when the red led begins blinking".A review of the certificate of conformance found that the driver passed all the release criteria.The device was released in 07/2009 and is approximately 9 years old.The complaint sample was never returned to teleflex for investigation purposes.The root cause cannot be established.The complaint cannot be confirmed.No corrective/preventative actions will be assigned.No further action required.
 
Event Description
It was reported that the driver appeared to run out of battery however the indicator light had not turned red prior to this.It was green prior to the driver stopping working.There was no patient injury.
 
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Brand Name
EZ-IO POWER DRIVER
Type of Device
CONNECTOR, AIRWAY (EXTENSION)
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key7681428
MDR Text Key114021847
Report Number3011137372-2018-00179
Device Sequence Number1
Product Code BZA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9058
Device Lot NumberG11026
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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