GEN4 Direct Access 4C331U-Z102798Recalls & reported problems
Curbell Medical Products, Inc. · GEN4 Direct Access · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840828119566), received between Oct 2, 2018 and Oct 2, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Integrity Problem1
Patient problems
- Burning Sensation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2018Material Integrity Problem; Material Integrity Problem
CURBELL MEDICAL ENGINEERING CONDUCTED AN ANALYSIS OF THE RETURNED PILLOW SPEAKER DEVICE. THIS UNIT WAS RETURNED FOR AN ALLEGED THERMAL EVENT WHERE THE VOLUME BUTTONS WERE EXCESSIVELY HOT, AROUND 154F AS REPORTED BY THE CUSTOMER. CURBELL MEDICAL ENGINEERING CONFIRMED THAT EVERYTHING IN THE UNIT WAS OPERATING AS EXPECTED, EXCEPT THE MICROPHONE FOR TALKBACK. IT WAS ALSO OBSERVED THAT THE VOLUME BUTTONS (OR AT LEAST THE AREA NEAR THESE BUTTONS) WAS HOT TO THE TOUCH. WITH THE UNIT INTACT AND UNASSEMBLED, THE UNIT WAS CONNECTED AND AT REST FOR 30 MINUTES. THE TEMPERATURE MEASURED AROUND THE VOLUME BUTTONS PEAKED AROUND 160F. THE UNIT WAS THEN REMOVED FROM SERVICE AND OPENED FOR INTERNAL REVIEW. IT WAS DISCOVERED THE C15 CAPACITOR (THE 100UF LINE LEVELING OUTPUT CAPACITOR FOR THE MAIN 5V REGULATOR) HAD ITS LEADS BROKEN AWAY FROM THE MAIN BODY OF THE CAPACITOR, FREE OF THE PRINTED CIRCUIT BOARD, AND WAS NOW ABLE TO MOVE WITHIN THE CASE ENCLOSURE. THE HEAT SOURCE WAS GENERATED BY THE 3.3V REGULATOR THAT TAKES ITS POWER FROM THE 5V REGULATOR. THIS 3.3V REGULATOR WAS REMOVED AND REPLACED AND FULL FUNCTIONALITY OF THE DEVICE WAS CONFIRMED. THEREFORE, IT IS OUR BELIEF THAT THE DEVICE WAS EXPOSE
Patient problems: Burning Sensation
MAUDE report 7925853 ↗
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- GEN4 DIRECT ACCESS 4C370U-P10424CCurbell Medical Products, Inc. · System, Communication, Powered3 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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