MAUDE Adverse Event Report: CARDINAL HEALTH CADENCE ZOLL PRECONNECT; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	22770PC
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the defibrillation electrode failed to discharge a charge to patient during code blue and a smart defibrillator used during the incident.Additional information was received and stated that the patient expired.Several attempts to gather information from the customer were made.To date, no response has been received.If additional pertinent information becomes available, the report will be updated.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured between 11-oct-2021 and 13-oct-2021.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.The current process is running according to product specifications, meeting all quality acceptance criteria.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: CADENCE ZOLL PRECONNECT
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CARDINAL HEALTH; 2 ludlow parkway; chicopee MA 01022
• 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: 13586720
• Report Number: 1219103-2022-00347
• Device Sequence Number: 11854455
• Product Code: MKJ
• UDI-Device Identifier: 20884527022394
• UDI-Public: 20884527022394
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 22770PC
• Device Catalogue Number: 22770PC
• Device Lot Number: 127814X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 04/26/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown