MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART XL; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 861290

Device Problems Use of Incorrect Control/Treatment Settings (1126); Failure to Deliver Shock/Stimulation (1133)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 10/06/2020

Event Type  Death  

Event Description

Patient was a coronary artery bypass graft x3 and post-op vasoplegia.Upon entrance to room lost blood pressure and pea (pulseless electrical activity) arrested.Dr.And rn were running the defibrillator.They finally got the patient into vfib, which was a shakable rhythm.The doctor asked them to charge and shock.The rn was unable to get the defibrillator to charge, or deliver a shock.All the cable connections were checked, and they were fine.After checking the defibrillator, it was noted that it was in sync mode.The rn was trying to cardiovert the patient instead of defibrillating him, but didn't recognize this.By the time we got it switched over, and charged again the patient already had gone back into pea, and we missed our opportunity.

• Brand Name: HEARTSTART XL
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10842657
• MDR Text Key: 216319883
• Report Number: 10842657
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 861290
• Device Catalogue Number: 861290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 23360 DA
• Patient Weight: 98