MAUDE Adverse Event Report: TOBII DYNAVOX LLC NAVIO MAXI AND NAVIO MIDI; SPEECH GENERATING DEVICE

Catalog Number	1000798
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Navio midi and navio maxi are speech-generating aac medical devices powered by an internal lithium-ion pouch battery.During repair intake on a device returned on february 10th for unrelated functional issues, fracture of internal battery mounting tabs was identified with evidence of prior drop or impact damage.The fractured internal housing contacted and compromised the prismatic lithium-ion battery casing, leading to an internal short circuit and localized thermal event with internal heating and battery gas venting; no thermal effects extended beyond internal components.The external enclosure remained intact, and no sustained fire or explosion occurred.Previously five cases involved fractured mounting tabs only, without battery pouch damage, internal short, thermal effects, heat, smoke, or user exposure.Those cases were initially assessed as non-reportable quality findings because no battery compromise, no hazardous situation, and no injury or potential for injury were identified at the time.The sixth case involving localized thermal runaway triggered escalation and reportability assessment.No health effects were observed in any case.No injuries, clinical signs, or symptoms occurred, and no medical intervention was required.The overall health impact is classified as no serious outcome, with the only observed effect being temporary device malfunction requiring repair.

• Brand Name: NAVIO MAXI AND NAVIO MIDI
• Common Device Name: SPEECH GENERATING DEVICE
• Manufacturer (Section D): TOBII DYNAVOX LLC; 1400 cherrington parkway; building 100; coraopolis PA 15108
• MDR Report Key: 24797451
• Report Number: 3004959902-2026-00001
• Device Sequence Number: 10679087
• Product Code: ILQ
• UDI-Device Identifier: 07340074602070
• UDI-Public: 07340074602070
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 03/12/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 1000798
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 04/07/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown