MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO POWER DRIVER

Catalog Number 9058

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

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 needle could not be drilled completely into the bone.The driver switched off before completion.There was no patient injury.

Manufacturer Narrative

Qn# (b)(4).The dhr file is not available for review in the us.The complaint sample 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".Other remarks: a review of the certificate of conformance found that the driver passed all the release criteria.The device was released in 06/2012 and is approximately 6 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 further action required.

Event Description

It was reported that the needle could not be drilled completely into the bone.The driver switched off before completion.There was no patient injury.

• Brand Name: EZ-IO POWER DRIVER
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 7591491
• MDR Text Key: 111175013
• Report Number: 3011137372-2018-00146
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Paramedic
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9058
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1