MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FR3, REFURB ECG AED - JAPANESE

Model Number	861389
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that the device speakers are not functioning properly.

• Brand Name: FR3, REFURB ECG AED - JAPANESE
• Common Device Name: AED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 11304178
• Report Number: 3030677-2021-00371
• Device Sequence Number: 14121157
• Product Code: MKJ
• UDI-Device Identifier: 00884838050389
• UDI-Public: (01)00884838050389
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: 861389
• Device Catalogue Number: 861458
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1