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

Model Number 22770PC

Device Problem No Pacing (3268)

Patient Problem Bradycardia (1751)

Event Date 08/29/2023

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 323786141
• Report Number: 1219103-2023-00371
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• 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
• Date Manufacturer Received: 08/30/2023
• 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): Required Intervention