MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART FR3; AED

Model Number 861389

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The user is questioning the analysis system of the device during a patient use event.The device appeared to be stuck in the analysis phase.The reporter of the issue stated the customer may have used an accessory device that is not approved by philips.The patient outcome is unknown.

• Brand Name: HEARTSTART FR3
• Type of Device: AED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• Manufacturer Contact: dana tackett ; 22100 bothell everett hwy; bothell, WA 98021
• MDR Report Key: 11059691
• MDR Text Key: 223731841
• Report Number: 3030677-2020-02121
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838049994
• UDI-Public: (01)00884838049994
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K130684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 861389
• Device Catalogue Number: 861389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1