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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
We have an ez io driver model 9065 , s/n (b)(4) , that no longer works.The crew attempted to use it on a call, when they pressed the trigger, the battery indicator briefly flashed red , the driver briefly moved rotated then stopped.We noticed that the casing near the top/side seems to be warped.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
We have an ez io driver model 9065 , s/n (b)(6), that no longer works.The crew attempted to use it on a call, when they pressed the trigger, the battery indicator briefly flashed red , the driver briefly moved rotated then stopped.We noticed that the casing near the top/side seems to be warped.
Additional Manufacturer Narrative
Qn#(b)(4).Ez-io driver 9058 (sn (b)(6)) was returned for evaluation.The sample is also associated with tc 20044242 for outer housing damage.Upon receipt, the driver was visually inspected.Visual inspection revealed significant thermal deformation to the housing which is indicative of the motor running continuously for an extended period of time.See tc 20044242 for additional details regarding the thermal deformation.When the trigger was pulled, the driver was inoperable, and no led light function was observed.The driver was opened to test and record operating characteristics.Battery voltage measured as 17.52 dc volts without being activated.Battery voltage measured as 0.44 dc volts when button was activated, and voltage reached a stable level.Stable defined as when whole numbers (e.G., 6 volts, 7 volts, etc.) stop changing (ignoring numbers after the decimal point).The motor and gearbox were connected to dc power supply and set to approximately 18v.When the trigger was pulled the motor and gear box were now operating as intended.A blinking red led light display was observed.The eeprom was parsed, and the results reveal the charge count was 32 ,711,307 and the cycle count was 90.The recorded charge count supports a depleted battery as the charge count has exceeded the maximum depletion value of 15,300,000.The cycle count of 90 is significant as it substantiates driver usage with considerations to bone density, average insertion time, storage, and frequency of testing.The eeprom also revealed that there were two extra-long trigger pulls (pulls greater than 5 minutes).This is significant as it explains the high charge count with low relative cycle counts.Extended trigger pulls accelerate battery aging.Testing confirms that the reported defect is due to extra-long trigger pulls.The ez-io driver ifu states, "as with any emergency medical device carrying a backup is strongly advised protocol", "when storing the vascular access pak (vap), remove the trigger guard to prevent accidental activation of the ez-io power driver." in summary, the complaint has been confirmed.The driver was returned with thermal deformation and was inoperable.The charge count was 32,711 ,307 and the cycle count (trigger pulls) was 90.The recorded charge count supports a depleted battery as the charge count has exceeded the maximum depletion value of 15,300,000 per ver0190 accel biotech firmware verification test report.The eeprom also revealed that there were two extra-long trigger pulls (pulls greater than 5 minutes).This is significant as it explains the high charge count with low relative cycle counts.Extended trigger pulls accelerate battery aging.A dhr review was performed with no evidence to suggest a manufacturing related cause.No other defects were revealed with the driver or its components during the investigation.Therefore, testing confirms that the reported defect is due to extra-long trigger pulls.The root cause is unintentional user error - storage.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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15494365
• Report Number: 3011137372-2022-00192
• Device Sequence Number: 14745270
• Product Code: FMI
• UDI-Device Identifier: 10816000013813
• UDI-Public: 10816000013813
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown