MAUDE Adverse Event Report: CARDINAL HEALTH CADENCE PHYSIO QC ADULT RTS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	22550R
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
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 straight out of the package, there was a noticeable cut/tear in the wire.The pad was replaced immediately.There was no harm to the patient.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported straight out of the package, there was a noticeable cut/tear in the wire.The pad was replaced immediately.There was no harm to the patient.
Additional Manufacturer Narrative
H3 evaluation summary: the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process.Quality assurance testing included an array of electrical tests.As part of the final assembly process of the defib electrode, each defib wire set is tested for continuity to ensure that the connector assembly can conduct current, and that it demonstrates electrical continuity.Finished goods wire testing is performed to ensure the finished product is working correctly.Lastly, prior to packaging the final defib electrode assembly, the product is 100% visually inspected.A sample was returned for evaluation.The sample returned showed a significant hole in the side of the wire.Some of the internal wires are broken/damaged.Finished goods wire testing was performed on the returned set and it failed.Given the information provided in the complaint and its investigation, no root cause could be identified related to manufacturing issues or deviations from the required specifications.Finished goods wire testing would have discovered this issue before release.From a corrective and preventative action standpoint, a quality alert has been issued to manufacturing both to elevate awareness and to notify of the reported condition.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
H6 investigation findings corrected from 4248 to 4247.

• Brand Name: CADENCE PHYSIO QC ADULT RTS
• 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: 13619342
• Report Number: 1219103-2022-00350
• Device Sequence Number: 4582078
• Product Code: MKJ
• UDI-Device Identifier: 20884527022332
• UDI-Public: 20884527022332
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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,Followup,Followup
• Report Date (Section B): 08/08/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 22550R
• Device Catalogue Number: 22550R
• Device Lot Number: 128500X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 02/24/2022; 02/24/2022; 02/24/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 04/25/2022; 08/02/2022; 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown