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

Model Number 861389

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It has been reported that the device speakers are not functioning properly.

• 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: 10596774
• MDR Text Key: 209225760
• Report Number: 3030677-2020-01582
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838049994
• UDI-Public: (01)00884838049994
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K130684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2020

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
• Device Operator: Health Professional
• Device Model Number: 861389
• Device Catalogue Number: 861389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 09/24/2020; 09/24/2020
• Supplement Dates FDA Received: 10/22/2020; 02/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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