MAUDE Adverse Event Report: CARDINAL HEALTH CADENCE ZOLL PRECONNECT; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number	22770PC
Medical Device Problem Code	No Pacing (3268)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the device will not be returned for evaluation because it has been discarded.
Event or Problem Description
Customer reports: the client needed to use the multifunction electrodes to do external pacing to a patient and it did not work.The electrode generated no pulse.Per additional information provided by the customer on (b)(6) 2023, despite the frequency of zoll set at 60 bpm, the patient remained bradycardium at 30 bpm (femoral pulse).The electrode seemed to receive a signal because we saw spicule at the monitor.We installed the electrodes to do external pacing and not defibrillation.The signal was inaccurate because the pulse requested at the zoll was 60 bpm, but the patient remained with a femoral pulse of 30 bpm.There was a delay to treatment, but not in defibrillation but rather in restoring the patient's pulse.We had to install a temporary endovenous pacemaker for the patient and we had to put isuprel and dopamine.The patient was discharged.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.If more information is received at a later date, the investigation will be reopened, and the investigation will be updated accordingly.

• Brand Name: CADENCE ZOLL PRECONNECT
• Common Device Name: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• 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: 17777709
• Report Number: 1219103-2023-00371
• Device Sequence Number: 5889498
• Product Code: DRO
• UDI-Device Identifier: 20884527022394
• UDI-Public: 20884527022394
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 10/09/2023

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: 22770PC
• Device Catalogue Number: 22770PC
• Device Lot Number: 223533X
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/09/2023
• 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: Required Intervention
• Patient Sex: Unknown