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

Model Number	22550PC
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the product was hooked up to a lifepak15 and it didn't defibrillate.The patient was ok.Per additional information received on (b)(6) 2022, the patient was under prolonged anesthesia due to the time taken to troubleshoot the defibrillator and apply new 3rd party defibrillator pads.Otherwise, there were no adverse effects to the patient as it was in a controlled environment for a cardioversion.
Additional Manufacturer Narrative
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 performed based on an acceptable quality limit level included an array of electrical tests; dc offset voltage, ac small signal impedance, defibrillation recovery, noise, large signal impedance, simulated defib recovery, pacing impedance, pacing offset voltage, wave form duration and pacing energy loss were performed.During production of the finished electrode there are two different steps whereby the connector is plugged into a receptacle (replicates plugging into therapy cord) that would cull out (reject the connector plug) any molding defects that would impair the connection.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.Should this continuity test fail, the product would be discarded.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.For lot 133576x the sets were made between december 13, 2021, and december 15, 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 of that sample to confirm the reported issue.However, in house samples were inspected for visuals and gel delamination, and electrical testing was performed.All pre-pacing, post-pacing, visual inspection, and gel delamination results were within acceptable tolerances.From a root cause analysis perspective, the investigation was unable to verify any causes related to the manufacturing process or deviations from the required specifications.If a sample is received at a later date, the complaint will be reopened and the investigation will be updated accordingly.From a corrective and preventative action standpoint, no further action is required at this time.We will continue to trend for future occurrences of the reported condition as part of the complaint review process.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Updated section d2 product code from dro to mkj.

• Brand Name: CADENCE PHYSIO PRECONNECT
• 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: 14547022
• Report Number: 1219103-2022-00356
• Device Sequence Number: 17288560
• Product Code: MKJ
• UDI-Device Identifier: 20884527022325
• UDI-Public: 20884527022325
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 08/09/2022
• 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: 22550PC
• Device Catalogue Number: 22550PC
• Device Lot Number: 133576X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 08/09/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown