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

Model Number 22550PC

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Asystole (4442); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/29/2022

Event Type  Death  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 301137208
• Report Number: 1219103-2022-00367
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 20192253017578
• UDI-Public: 20192253017578
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 09/29/2022; 09/29/2022
• Supplement Dates FDA Received: 10/06/2022; 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death