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 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation results are pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during resuscitation the drivers lost power and had reduced rotations.A back-up device was used.There was no reported patient injury.

Event Description

It was reported that during resuscitation the drivers lost power and had reduced rotations.A back-up device was used.There was no reported patient injury.

Manufacturer Narrative

(b)(4).The dhr file is not available for review in the us.Ez-io driver 9058 (sn h48573) 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: c05180) 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: 3.50, insertion 2: 3.00, insertion 3: 2.85, other remarks: hard profile (105 lbs/ft3), insertion 1: 7.53, insertion 2: 7.35, insertion 3: 9.72.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 06/2013 and is approximately 5 years old.The customer's complaint that the driver failed during use cannot be confirmed.The driver successfully negotiated the soft and hard saw bone insertion test.No corrective/preventative actions will be assigned.Functional testing has validated no fault found with this driver.No further action required.

• 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: 7267085
• MDR Text Key: 100131137
• Report Number: 3011137372-2018-00034
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9058
• Device Lot Number: H48573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: No
• 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