MAUDE Adverse Event Report: WELCH ALLYN INC SPOT VISION SCREENER,W/CASE,PLUGB/US; REFRACTOMETER, OPHTHALMIC

Model Number	VS100S-B
Medical Device Problem Codes	Fire (1245); Explosion (4006)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A video tape was received from the customer which showed the unit sitting unplugged on the counter emitting smoke and the unit then caught fire.Per the customer, the unit began to audibly 'pop' several times and then they began videotaping.The unit has been requested to be returned to the manufacturer for inspection.A final report will be submitted upon completion of the investigation.
Event or Problem Description
Customer reported the battery had exploded several times and the device had caught on fire.There was no adverse event reported.
Event or Problem Description
Customer reported the battery had exploded several times and the device had caught on fire.There was no adverse event reported.
Additional Manufacturer Narrative
The battery was returned to the manufacturer for inspection where it showed both the protection board and output leads remained intact, confirming they were not contributors to the failure.The customer¿s charging voltage, current, and termination method were within the specified limits.No evidence suggests the charger induced abnormal stress on the pack.The suggested battery replacement period is every 2.5 years.The device had not been returned for service since 2021.The battery manufacturer determined that the root cause of the reported incident was prolonged operation without replacement, leading to lithium crystal buildup, separator penetration, and internal shorting.This failure mode is a well-known risk when lithium-ion packs are kept in service past their designed replacement interval.The spot vs100 is intended for vision screening of subjects from the age of 6 months through adults.The device evaluates a subject¿s refraction, pupil size and visual gaze for determining the need for referral to for further evaluation.A medical (vision) professional.Spot vs100 is indicated for use when evaluation of individuals for poor vision and refractive errors is needed.Although there was no injury associated with this event, if the reported incident were to recur, it could lead to serious injury or death.

• Brand Name: SPOT VISION SCREENER,W/CASE,PLUGB/US
• Common Device Name: REFRACTOMETER, OPHTHALMIC
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 22529989
• Report Number: 1316463-2025-00071
• Device Sequence Number: 20704965
• Product Code: HKO
• UDI-Device Identifier: 00732094212228
• UDI-Public: 732094212228
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 09/10/2025

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: VS100S-B
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 09/10/2025
• 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