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

Model Number M4735A

Device Problem Failure to Charge (1085)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 03/28/2020

Event Type  Death  

Event Description

During cpr nurse went to charge defibrillator and the machine would not charge.It was attempted 3 times with no success before switching out to a new machine while patient coding.The patient had received roughly 40 -50 minutes of cpr prior to this malfunction.

• 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: 9932907
• MDR Text Key: 186704371
• Report Number: 9932907
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4735A
• 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: 03/31/2020
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 24820 DA
• Patient Weight: 136