AM282 MANUAL AUDIOMETER W/CASE
Report
- Report Number
- 1316463-2025-00096
- Event Type
- Malfunction
- Date Received
- December 31, 2025
- Date of Event
- December 4, 2025
- Report Date
- January 13, 2026
- Manufacturer
- GRASON STADLER GSI
- Product Code
- ETY
- UDI-DI
- 00732094082319
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
UPON INVESTIGATION THE CUSTOMER FOUND THAT THE POWER SUPPLY HAD FRAYED COPPER WIRING TOWARDS THE SECTION THAT CONNECTS INTO THE OUTLET. THE DEVICE HAS BEEN RETURNED FOR FURTHER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.
THE DEVICE WAS RETURNED FOR INSPECTION WHERE IT WAS FOUND THAT THE CUSTOMERS ALKALINE BATTERIES HAD LEAKED INSIDE THE UNIT. POTASSIUM CARBONATE WAS VISIBLE FROM THE OUTSIDE OF THE HOUSING. THE TECHNICIAN ALSO FOUND EXPOSED COPPER WIRES ON THE POWER SUPPLY. THE WELCH ALLYN AM282 AUDIOMETER IS INTENDED TO BE USED FOR THE IDENTIFICATION AND ETIOLOGY OF HEARING LOSS IN PATIENTS OF ANY AGE. IT IS INTENDED TO BE USED BY AN AUDIOLOGIST, ENT, HEARING HEALTHCARE PROFESSIONAL, OR TRAINED TECHNICIAN IN A HOSPITAL, CLINIC, HEALTHCARE FACILITY OR OTHER SUITABLE QUIET ENVIRONMENT. THERE ARE NO CONTRAINDICATIONS FOR THE WELCH ALLYN AM282 AUDIOMETER. THE INSTRUCTIONS FOR USE RECOMMENDS TO ALWAYS INSPECT BATTERIES FOR LEAKAGE AND DO NOT USE IF THE BATTERIES SHOW ANY SIGNS OF DAMAGE. IT ALSO STATES THAT PARTS WHICH MAY BE BROKEN OR MISSING OR ARE PLAINLY WORN, DISTORTED OR CONTAMINATED SHOULD BE REPLACED IMMEDIATELY WITH CLEAN, GENUINE REPLACEMENT PARTS MANUFACTURED BY OR AVAILABLE FROM WELCH ALLYN. THE DEVICE WAS REPLACED TO RESOLVE THE REPORTED ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTIONS ARE REQUIRES AT THIS TIME.
UPON FURTHER REVIEW IT WAS NOTED THAT THIS IS A DISTRIBUTED PRODUCT, BAXTER IS NOT THE LEGAL MANUFACTURER. THE SUPPLIER (B)(4) HAS BEEN NOTIFIED ABOUT THIS COMPLAINT. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.
CUSTOMER REPORTED THAT THE BATTERIES WITHIN THE UNIT HAD EXPLODED. THERE WAS NO INJURY TO ANYONE OR ANY DAMAGE TO THE FACILITY. IT WAS REPORTED THE INCIDENT HAPPENED WHEN THE UNIT WAS PLUGGED INTO THE OUTLET WITH THE POWER SUPPLY.
CUSTOMER REPORTED THAT THE BATTERIES WITHIN THE UNIT HAD EXPLODED. THERE WAS NO INJURY TO ANYONE OR ANY DAMAGE TO THE FACILITY. IT WAS REPORTED THE INCIDENT HAPPENED WHEN THE UNIT WAS PLUGGED INTO THE OUTLET WITH THE POWER SUPPLY.
CUSTOMER REPORTED THAT THE BATTERIES WITHIN THE UNIT HAD EXPLODED. THERE WAS NO INJURY TO ANYONE OR ANY DAMAGE TO THE FACILITY. IT WAS REPORTED THE INCIDENT HAPPENED WHEN THE UNIT WAS PLUGGED INTO THE OUTLET WITH THE POWER SUPPLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2585239 | AM282 MANUAL AUDIOMETER W/CASE | TESTER, AUDITORY IMPEDANCE | ETY | GRASON STADLER GSI | 28200 | 00732094082319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |