ER9W CDMA wEvent 900-0612-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B146ER9WCNC0), received between May 10, 2018 and May 10, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2018Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  BRAEMAR RECEIVED INFORMATION ON 04/12/2018 FROM OUR DISTRIBUTOR IN WHICH THEY REPORTED AN ADVERSE INCIDENT INVOLVING ONE OF THE BRAEMAR ER920W EVENT RECORDERS AND A DISPOSABLE LITHIUM THIONYL CHLORIDE BATTERY. THE DISTRIBUTOR INFORMED BRAEMAR A BATTERY RUPTURED/EXPLODED IN THE DEVICE IN A PATIENTS HOME WHILE THE DEVICE WAS SITTING ON A TABLE. NO PATIENT INJURY WAS REPORTED. AS THE RESULT OF THE REVIEW OF PHOTOS RECEIVED OF THE RUPTURED BATTERY AND RESULTING DAMAGE OBSERVED ON THE RETURNED DEVICE, IT WAS DETERMINED THIS EVENT COULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS EVENT IF IT WERE TO RECUR, AND IS THEREFORE BEING REPORTED TO THE FDA PER 21 CFR 803 AS AN MDR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7502965 ↗