MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO POWER DRIVER; NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN915667
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported event: the driver's led was still glows green but had a significant drop in performance when used on the patient, so the yellow needle could not be inserted into the proximal tibia.Whether the puncture site was correct is unknown.According to the customer, the driver ran normally at first, then it became heavier and finally stopped.It is not known and could not be determined whether the pressure was increased.The driver was used during a resuscitation.The io needle was inserted manually with no patient injury.The malfunction did not contribute to the patient's condition.
Additional Manufacturer Narrative
Qn# (b)(4).The device investigation is pending and a follow-up report will be issued after the investigation is completed.
Event or Problem Description
Reported event: the driver's led was still glows green but had a significant drop in performance when used on the patient, so the yellow needle could not be inserted into the proximal tibia.Whether the puncture site was correct is unknown.According to the customer, the driver ran normally at first, then it became heavier and finally stopped.It is not known and could not be determined whether the pressure was increased.The driver was used during a resuscitation.The io needle was inserted manually with no patient injury.The malfunction did not contribute to the patient's condition.
Additional Manufacturer Narrative
Qn#(b)(4) ez-io driver 9058 was returned for evaluation.Upon receipt, the driver was visually inspected.When the trigger was pulled, the driver was operable, and a solid green led light was displaying.The driver was then subjected to simulated sawbone insertions per driver ifu.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 and hard hardness profiles with 3mm cortexes were used for the test.Each insertion was timed with a stopwatch while applying approximately 8 lbs.Of force on a weight scale.Approximately 5 to 8 lbs.Of force are necessary to penetrate bone.The driver successfully negotiated both the medium and hard saw bone insertion testing.The complaint cannot be confirmed.The driver was opened to test and record operating characteristics.Battery voltage measured as 17.75 dc volts without being activated.Battery voltage measured as 14.46 dc volts when button was activated, and voltage reached a stable level.Stable defined as wh en whole numbers stop changing (ignoring numbers after the decimal point).The measured voltage is slightly lower than the nominal specification of 18.2v for the battery pack upon release.This is expected after device use.The eeprom was parsed, and the results reveal the charge count was 2,507,282 and the cycle count was 376.The cycle count of 376 trigger activations is significant as it substantiates driver usage with considerations to bone density, average insertion time, storage, and frequency of testing.The eeprom results confirm that the battery is not depleted as the charge count has not exceeded the maximum depletion value of 15,300,000 per ver0190 accel biotech firmware verification test report.Additionally, 1 stall condition was recorded.The ez-io needle ifu states, "squeeze trigger and apply gentle, steady pressure.Important: do not use excessive force.Note: if ez-io power driver stalls and ez-io needle set will not penetrate the bone, operator may be applying too much downward pressure to penetrate bone." a copy of the manufacturing device history file was reviewed.No recorded results of manufacturing issues or anomalies were reported.Testing confirms that there was no fault found with the returned driver.A review of the device history record found that the driver passed all the release criteria.The device was released in 09/2017 and is approximately 5.5 years old.The complaint cannot be confirmed.Functional testing revealed no fault found with this driver as the device was able to negotiate both the medium and hard saw bones during insertion testing.No defects or anomalies were observed with the returned driver.The eeprom results confirm that the battery is not depleted.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: EZ-IO POWER DRIVER
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LU
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16368985
• Report Number: 3011137372-2023-00027
• Device Sequence Number: 20675236
• Product Code: FMI
• UDI-Device Identifier: 10816000013813
• UDI-Public: 10816000013813
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN915667
• Device Catalogue Number: 9058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown