MAUDE Adverse Event Report: CONMED CORPORATION PADPRO; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	2516Z
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An elderly person experienced atrial fibrillation while on vacation and he presented to local cardiologist for evaluation and then pursued electrical cardioversion.Patient was brought to bronch room, attached to lifepak.First set of patches defective where the adhesive stuck to paper instead of patch.Rn reapplied different set of patches.Patient sedated and lifepak turned on and synched to patient's rhythm.Upon charging machine, the patient had a slight change in rhythm, continued in atrial fibrillation (a-fib).Life pak unsynched with patient.Rn immediately dumped charge and procedure started again.Doctors are in room and process restarted.The lifepak resynched and charged to appropriate joules and synch was lost again, charge dumped.New pads applied and cardioversion attempted and succeeded this time with no loss of synch mode for cardioversion.Rn noted there had recently been 6 to 8 pad sets tossed during previous procedures however, no dates, no lot numbers retained.The cardiopulmonary lab personnel retained these 3 sets in this report and saved packages and devices which are all the same lot number.No patient harms.

• Brand Name: PADPRO
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 15401222
• Report Number: 15401222
• Device Sequence Number: 14704203
• Product Code: MKJ
• UDI-Device Identifier: 10653405042525
• UDI-Public: (01)10653405042525
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/06/2022
• Report Date (Section F): 09/06/2022

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
• Operator of Device: Health Professional
• Device Model Number: 2516Z
• Device Catalogue Number: 2516Z
• Device Lot Number: Y02162203
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 137 KG
• Patient Race: White
• Date Report Sent to FDA: 09/06/2022