MAUDE Adverse Event Report: CARDINAL HEALTH 1310P MEDITRACE 2/PK 20/CA; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	31319281
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a male patient was having a procedure in the cvor.He was being monitored by the anesthesia monitor and the defibrillator.The patient coded and was shocked one time at 200.Then he was shocked a second time at 300 and immediately after the second shock, the defibrillator was no longer monitoring.The patient was still being monitored by the anesthesia monitor.Per the customer, the patient expired but it was not due to the electrode.Additional information received on (b)(6) 2022 stated that the procedure being done was vats.The monitor being used was a lifepak 20e.The monitor was still on and functioning with no signal from the pads.The patient's cause of death was due to severe lung and cardiac disease.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were no deviations and no nonconformances initiated with this lot code.There were no samples submitted with this complaint; however, the complaint will be reopened if a sample is later received.Because no sample was returned with this complaint, no physical product examination was possible to confirm the reported conditions of no reading.Had a sample been received, it would have been evaluated against the established product requirements.A probable root cause could not be determined because no samples were submitted to examine for the reported condition and the complaint could not be confirmed.Current manufacturing practices require production to be sampled and inspected through a series of functional and visual testing based on valid aql sampling plans to ensure good connectivity and shock delivery.Functional testing performed on this product includes but is not limited to electrical properties testing, energy transmission by simulating defibrillation testing, gel weight measurements, pull force testing, and residual monomer testing.Likewise, visual inspections are performed based on aql sampling where construction, alignment, packaging and labeling of product are examined to ensure all product requirements are met prior to release.Production employees also perform 100% visual inspection as part of manufacturing requirements.Since this complaint is unconfirmed and no complaint trend exists and a specific root cause for the occurrence cannot be identified, no corrective action is required at this time.This complaint will be recorded for tracking and trending purposes.

• Brand Name: 1310P MEDITRACE 2/PK 20/CA
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15756733
• Report Number: 9681860-2022-00530
• Device Sequence Number: 11980272
• Product Code: MKJ
• UDI-Device Identifier: 20192253017721
• UDI-Public: 20192253017721
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 31319281
• Device Catalogue Number: 31319281
• Device Lot Number: 221707X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 11/18/2022
• 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: Male
• Patient Weight: 69 KG