MAUDE Adverse Event Report: CARDINAL HEALTH ELECTRODE ADULT 4.5X6.25 DEFIBRILATION; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	22550A
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that when using the device, the plate connector was not attached to the defibrillator.The connector appeared bent and that prevented it from connecting.The customer further stated that the device had been stored properly and the packaging was opened at the time of use.There was no harm to the patient involved.Additional information was received from the customer and stated that the part involved in the issue was a bend in the first metal pin, the one near the fixing tab (the first from the top) inside its protective part, which was neither crushed nor damaged.It was folded and resting against the wall of the protection and prevented it from fitting onto the cable socket.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Per customer, the physical sample was discarded; however, a picture was provided for evaluation which showed the connector plug but didn¿t show the reported issue.Because a physical sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and determine the root cause.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: ELECTRODE ADULT 4.5X6.25 DEFIBRILATION
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 19163224
• Report Number: 1219103-2024-00001
• Device Sequence Number: 7085486
• Product Code: MKJ
• UDI-Device Identifier: 20192253017547
• UDI-Public: 20192253017547
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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
• Device Model Number: 22550A
• Device Catalogue Number: 22550A
• Device Lot Number: 324307X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown