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

Model Number	22550PC
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Asystole (4442); Heart Failure/Congestive Heart Failure (4446)
Date of Event	09/29/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: four defib pads were opened for use during a resuscitation situation and an attempt was made to stick them to the patient, but they did not stick and slipped off the patient's chest.Rhythm control and defibrillation were not possible at that time.Per additional information received on 10/04/2022, the patient died.
Additional Manufacturer Narrative
Updates were made to the following sections: section b7: additional information was provided on 10/06/22 stating that the patient had a non-defibrillable heart rhythm (asystole) and therefore could not be defibrillated.Section h6: health effect - clinical code updated to add code 4442.
Additional Manufacturer Narrative
A review of the device history records (dhr) yielded no discrepancies within the manufacture of the affected lot number reported.Samples were returned for this case.The samples were inspected and found to adhere properly.There were no issues found with any of the returned samples.The company held retain samples for both the subassembly and the finished product were inspected.Visually no issues were found with the product.The subassembly gel bodies were inspected for texture analyzer and single direction peel with values in line with normal product in the field.From a root cause analysis perspective, the investigation was unable to determine any possible manufacturing causes for the adhesion issues.Proper skin preparation is important to adhesion of any product.If the patient¿s skin is compromised due to age, health, or skin condition, this could result in adhesion issues.The electrodes have two parts which both assist in the adhesion of the product.The foam carrier is the main adhesion for the product which the gel pad and secondary, they both assist in adhering the product to the patient¿s skin.The results of the manufacturing facility investigation were unable to attribute any potential root causes associated with the manufacturing of the product which would have contributed to the adhesion issue as stated.Based upon the investigative details and the root cause evaluation, no corrective or preventative actions are required to be taken at this time in relation to the customer described event.We will continue to trend the reported issue for future occurrences as part of the complaint review process.

• Brand Name: CADENCE PHYSIO QC ADULT RTS
• 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: 15538912
• Report Number: 1219103-2022-00367
• Device Sequence Number: 7083763
• Product Code: MKJ
• UDI-Device Identifier: 20192253017578
• UDI-Public: 20192253017578
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2022

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: 22550PC
• Device Catalogue Number: 22550PC
• Device Lot Number: 134267X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 09/29/2022; 09/29/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 10/06/2022; 11/09/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown