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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
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.
 
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Brand NameNA
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
22100 bothell everett hwy
bothell WA 98021
MDR Report Key11193317
MDR Text Key227524844
Report Number11193317
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number861288
Device Catalogue NumberM3535A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/23/2020
Event Location No Information
Date Report to Manufacturer01/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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