MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART; DEFIBRILLATOR

Model Number	M3713A
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	09/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to philips that, during a cardiac arrest, electrode pads m3713a were applied to the patient and connected to the defibrillator.The patient had regained pulse and was in arrhythmia.After connecting to the defibrillator, the device would not charge.The device was swapped for two other devices.The new pads were applied to get a successful cardioversion.Additional details have been requested.Although no direct adverse event to the patient or user was reported, we are considering this to be a serious injury due to a serious deterioration in the state of health of the patient because life-saving therapy/treatment may have been interrupted/delayed.
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This complaint has been deemed a duplicate of (b)(4) already reported on mdr number (b)(4).
Event or Problem Description
This complaint has been deemed a duplicate of (b)(4) already reported on mdr number (b)(4).

• Brand Name: HEARTSTART
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: laura scanlan ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 16092408
• Report Number: 3030677-2023-00022
• Device Sequence Number: 15081085
• Product Code: MKJ
• UDI-Device Identifier: 00884838002845
• UDI-Public: 00884838002845
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K002806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M3713A
• Device Catalogue Number: M3713A
• Device Lot Number: 050520-02
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown