FDA Adverse Event Malfunction Summary report: N

AIRPODS PRO (2ND GENERATION)

MDR report key: 21220969 · Received January 22, 2025

Report

Report Number
MW5165160
Event Type
Malfunction
Date Received
January 22, 2025
Date of Event
September 15, 2024
Report Date
January 16, 2025
Manufacturer
APPLE INC.
Product Code
SCR
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

IN (B)(6) 2024 I PURCHASED APPLE AIRPODS PRO IN ANTICIPATION OF A SOFTWARE UPDATE TO INCLUDE A HEARING AID FUNCTION IN THE DEVICE. WHEN AVAILABLE IN SEPTEMBER, I DOWNLOADED THE UPDATE AND TRIED REPEATEDLY TO COMPLETE THE HEARING TEST IN THE PRODUCT, WITHOUT SUCCESS. SINCE THEN I HAVE HAD COUNTLESS PHONE CONVERSATIONS WITH APPLE PRODUCT SUPPORT, WHICH HAS CLAIMED IT WAS ATTEMPTING TO SOLVE THE PROBLEM, INCLUDING THROUGH A TECHNICAL ANALYSIS OF AN ATTEMPTED (AND UNSUCCESSFUL) HEARING TEST, BUT WITHOUT ANY RESULTS PROVIDED TO ME. I EXPLAINED THAT I PURCHASED THE PRODUCT ONLY FOR THE HEARING AID FUNCTION AND REQUESTED A REFUND, BUT WAS TOLD THAT THE TIME FOR THE PRODUCT RETURN HAS PASSED, EVEN THOUGH THE PRODUCT IS STILL WELL WITHIN THE ONE-YEAR WARRANTY PERIOD. I BELIEVE THAT APPLE HAS MISREPRESENTED THE EFFECTIVENESS OF WHAT IS IN FACT A DEFECTIVE MEDICAL PRODUCT AND IS REFUSING TO TAKE RESPONSIBILITY FOR THIS DEFECTIVE DEVICE. APPLE SUPPORT HAS CLAIMED TO COPY A FAILED HEARING TEST ON MY AIRPODS FOR TECHNICAL ANALYSIS IN ITS LABORATORIES. HOWEVER, IT HAS NOT PROVIDED ME WITH ANY RESULTS. FOR DETAILS, YOU WILL NEED TO CONTACT APPLE. MY CASE ID NO. IS (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
607031 AIRPODS PRO (2ND GENERATION) AIR-CONDUCTION HEARING AID SOFTWARE SCR APPLE INC. A3047

Patients

Seq Age Sex Outcome Treatment
1 77 YR Prefer Not To Disclose