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

Model Number	453564675561
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was a cardiac arrest.The code team arrived and initiated advanced cardiac life support (acls) protocol.The patient's rhythm changed from pulseless electrical activity (pea) to vfib at 2332.Rn attempted to charge the defibrillator to 150j and shock, only 120j were delivered per rhythm strip that was printed.After shock delivered the defibrillator did not show a rhythm so the leads had to be placed on the patient.Then it was determined the patient was in sinus rhythm.

• Brand Name: HEARTSTART PAD CONNECTOR CABLE
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 7965113
• Report Number: 7965113
• Device Sequence Number: 182726
• Product Code: MKJ
• UDI-Device Identifier: 00884838002753
• UDI-Public: (01)00884838002753(10)06-16
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2018
• Report Date (Section F): 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 453564675561
• Device Catalogue Number: M3508A
• Device Lot Number: 06-16
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 102
• Date Report Sent to FDA: 09/27/2018