MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC. CARDINAL KENDALL; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 1310P

Device Problems No Display/Image (1183); Sensing Intermittently (1558); Defibrillation/Stimulation Problem (1573)

Patient Problem Tachycardia (2095)

Event Date 10/31/2022

Event Type  Death  

Event Description

After 2nd shock, pads no longer transmitting rhythm to defibrillator.Vats procedure.Hr/ rhythm displayed on defib as well as anesthesia monitor.Pt coded, immediately following 2nd shock (300) hr/ rhythm was no longer visible on defib.Hr was still being monitored on anesthesia monitor.At no time was pt not monitored.Code was slopped and pt pronounced deceased.Two (2) other defibrillators as well as stock of defib pads were available in unit it needed.Pt death was due to medical condition, not potential equipment issue.Defibrillator was sequestered and checked by biomed and found to be functioning properly.Reporting as potential issue with defib pads.Pads in trash and unable to be retrieved.Severe copd, htn, hf, cardiomyopathy, thoracic outlet syndrome.

• Brand Name: CARDINAL KENDALL
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC.; 3651 birchwood dr.; waukegan IL
• MDR Report Key: 15743796
• MDR Text Key: 303228050
• Report Number: MW5113074
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/02/2022

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: 1310P
• Device Catalogue Number: 31319281
• Device Lot Number: 221707X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American