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

Model Number 861288

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Ventricular Fibrillation (2130)

Event Date 12/22/2020

Event Type  malfunction  

Event Description

Stemi patient arrived to the cardiac cath lab with inferior/posterior changes and complete heart block.The cardiologist performed a left heart cath which revealed a 100% occluded right coronary artery (rca).Once the culprit lesion was identified the team prepared for coronary intervention.A judkins right coronary catheter 4cm (jr4) guide was introduced with a run-through wire being placed distal to the lesion.From there pre-dilation was performed using a 2mm and 3mm nc balloon.While using the 3mm balloon, the patient developed v-fib requiring defibrillation; 150j shock was selected with 152j shock being delivered (within specifications).According to the cardiologist, approximately 10-15 seconds after the first shock was delivered a second shock was delivered the patient.The cardiologist felt the shock as he was holding/manipulating the catheters at the time.The device was not set to deliver a second shock, nor were staff around to push the shock button.The device was removed from service and taken to our clinical engineering department for interrogation.Initial review of the logs confirms the first shock of 152j was delivered, however there is no indication a second shock was requested nor delivered.The patient was not negatively impacted by the second shock.

• Brand Name: NA
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 11193317
• MDR Text Key: 227524844
• Report Number: 11193317
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 861288
• Device Catalogue 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: 12/23/2020
• Date Report to Manufacturer: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA