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

Device Problems Thermal Decomposition of Device (1071); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2017

Event Type  malfunction  

Event Description

Sparks flew from right defibrillator paddle during the daily defibrillator check.The paddles were confirmed to be in place, machine charged to 150j, and sparks flew during discharge of machine from its right paddle.Burn marks noted to both paddle and inside cradle.The machine was impounded and sent to bio med.Manufacturer response for defibrillator, heartstart (per site reporter): device held at (b)(6) for onsite vendor review.The vendor had not arrived to examine device.

• Brand Name: HEARTSTART
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 6746506
• MDR Text Key: 81145626
• Report Number: 6746506
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/01/2017,07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NA-NOT ATTACHED TO PATIENT