MAUDE Adverse Event Report: GRASON STADLER GSI AM282 MANUAL AUDIOMETER W/CASE; TESTER, AUDITORY IMPEDANCE

Model Number	28200
Medical Device Problem Codes	Explosion (4006); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: AM282 MANUAL AUDIOMETER W/CASE
• Common Device Name: TESTER, AUDITORY IMPEDANCE
• Manufacturer (Section D): GRASON STADLER GSI; 10395 w 70th st; eden prairie MN 55344
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 23933030
• Report Number: 1316463-2025-00096
• Device Sequence Number: 17577564
• Product Code: ETY
• UDI-Device Identifier: 00732094082319
• UDI-Public: 732094082319
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2026

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
• Device Model Number: 28200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 12/11/2025
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 01/07/2026; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown