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

Model Number M3535A

Device Problem No Display/Image (1183)

Patient Problems Cardiopulmonary Arrest (1765); Loss of consciousness (2418); Loss Of Pulse (2562)

Event Date 03/11/2019

Event Type  malfunction  

Event Description

Patient was unresponsive, pulseless and not breathing adequately.Cpr was in progress and when i went to put the defibrillator pads on the patient, the monitor would not display a heart rhythm.Csi team notified.Biomed notified.Leadership notified.

• Brand Name: HEARTSTART MRX
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 8691327
• MDR Text Key: 147777805
• Report Number: 8691327
• 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: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3535A
• 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: 04/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16425 DA