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

Model Number 2001Z-C

Device Problems Device Emits Odor (1425); Sparking (2595)

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 10/29/2022

Event Type  malfunction  

Event Description

Elderly patient had a sudden decrease in oxygen levels and level of consciousness.A code was called and advanced cardiac life support (acls) was started.During the first defibrillation attempt, sparks and a smoke smell were noted.There was no apparent harm to the patient from the spark event.The defibrillator pads were adjusted for better skin adherence and a subsequent defibrillation attempt was performed successfully without problems.Return of spontaneous circulation was achieved with a weak, thready pulse and hypotension.The best explanation is the pads were not fully adhered to the patient¿s skin, likely due to the hurriedness of the situation, contributing to the spark and smoke.The pads were adjusted for better adherence and a subsequent defibrillation attempt did not have problems.

• Brand Name: PADPRO
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502
• MDR Report Key: 16443040
• MDR Text Key: 310247933
• Report Number: 16443040
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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 Operator: Health Professional
• Device Model Number: 2001Z-C
• Device Catalogue Number: 2001Z-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Sex: Male