MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FR3, REFURB TEXT AED, LANGUAGE CONFIGURA

Model Number 861388

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: FR3, REFURB TEXT AED, LANGUAGE CONFIGURA
• 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: 10623016
• MDR Text Key: 209763635
• Report Number: 3030677-2020-01614
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K111693
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 861388
• Device Catalogue Number: 861388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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