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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO POWER DRIVER
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TELEFLEX MEDICAL EZ-IO POWER DRIVER Back to Search Results
Catalog Number 9058
Device Problem Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/20/2018
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
Issue reported the device was used during a cardiac arrest on a difficult vascular access patient.When engaging the driver in air it worked fine and the green light was on.During insertion of the needle through the bone it felt as though the driver lost power and stopped rotating.It was reported that the device not working did not play a role in the outcome of the patient.
 
Manufacturer Narrative
Qn#(b)(4).The dhr file is not available for review in the us.Ez-io driver 9058 (sn (b)(4) ) was returned for evaluation.Upon receipt, the driver was visually inspected.No obvious signs of damage were observed.When the trigger was pulled the driver was operable and a solid green led light displaying.Ez-io driver 9058 (sn (b)(4) ) was returned for evaluation.Upon receipt, the driver was visually inspected.No obvious signs of damage were observed.When the trigger was pulled the driver was operable and a solid green led light displaying.The driver was then subjected to simulated sawbone insertions.This functional test is used to determine whether the returned device still has the capability to power a 45mm ez-io needle set into a medium and/or hard bone.The 45mm ez-io needle set is used because it represents the worst case scenario for io insertion.Two (2) sawbones with medium (50 lbs/ft3) and hard (105 lbs/ft3) hardness profiles with 3mm cortexes were used for the test.Each insertion was timed with a stopwatch (id: (b)(4)) while applying approximately 8 lbs.Of force on a weight scale (id: c05318).Approximately 5 to 8 lbs.Of force is necessary to penetrate bone.Below are the test results: medium profile (50 lbs/ft3); insertion 1: 5.57, insertion 2: 4.28, insertion 3: 3.78.Hard profile (105 lbs/ft3); insertion 1: 11.47, insertion 2: 10.54, insertion 3: 10.38.The driver successfully negotiated both the soft and hard saw bone insertion testing.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 (b)(6)2009 and is approximately 8.5 years old.The complaint cannot be confirmed.Functional testing has confirmed no fault found with this driver.No corrective/preventative actions will be assigned.Functional testing has confirmed no fault found with this driver.No further action required.
 
Event Description
Issue reported the device was used during a cardiac arrest on a difficult vascular access patient.When engaging the driver in air it worked fine and the green light was on.During insertion of the needle through the bone it felt as though the driver lost power and stopped rotating.It was reported that the device not working did not play a role in the outcome of the patient.
 
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Brand Name
EZ-IO POWER DRIVER
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key7694235
MDR Text Key114675455
Report Number3011137372-2018-00188
Device Sequence Number1
Product Code GEY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9058
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2018
Date Manufacturer Received07/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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