MAUDE Adverse Event Report: CARDINAL HEALTH MEDITRACE RTS FOR ZOLL; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	20770
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 that the defibrillator pads for zoll (kendall 20770 adult multi-function defibrillation electrodes) sparked a small flame when defibrillating a patient in v-fib in the emergency room causing a lucas machine owned by amr to short circuit.Pads were noted to be properly secured to the patient prior to event and plugged in properly.Zoll was functioning properly as well and had passed the safety checks for the day.Additional information received from the customer on 21-mar-2022 stated that there was no patient injury or death.The instructions for use were followed for skin prep.It is unknown if the electrode area was free of hair or dry.Along with the defib, the patient had ekg wires, oxygen, and an et tube.It is unknown how many shocks the patient received and unknown how many joules.It is not known when or where on the device the spark/flame occurred.The flame went out on it's own.Patient information is unknown.
Additional Manufacturer Narrative
Per the complaint report no samples are expected.A review of the device history record was not performed during this investigation as a viable lot number was not received with the complaint.All device history records are reviewed and approved by quality prior to release of product.With no lot number, a date of manufacture could not be determined.Since there were no samples received with this complaint an examination of the device could not be made.The results of the manufacturing facility investigation were unable to confirm any potential root causes associated with the manufacture of product which would have contributed to the reported condition.Furthermore, testing is performed to mitigate any issues during the manufacturing process.Based on the available information, no corrective or preventative actions are necessary at this time.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Updated section d2 product code from dro to mkj.

• Brand Name: MEDITRACE RTS FOR ZOLL
• 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: 13875593
• Report Number: 1219103-2022-00353
• Device Sequence Number: 11928698
• Product Code: MKJ
• UDI-Device Identifier: 20884527015617
• UDI-Public: 20884527015617
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• 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: 20770
• Device Catalogue Number: 20770
• 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: 02/22/2022
• Supplement Date Received by Manufacturer: 02/22/2022; 02/22/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/21/2022; 08/08/2022
• 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