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

Model Number	VS100S-B
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The power supply was received by baxter.Upon inspection, it was determined that the charging brick cord where it is inserted into the device had copper wires exposed.A replacement power supply was sent to the customer.Based on this information, no further actions are required at this time.Although there was no reported injury with this event, if the report of a damaged power supply with exposed wires were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.
Event or Problem Description
It was reported that vs100 charging strain relief had copper wires showing.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint#: (b)(4).

• 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: daniela avila ; 4341 state street; skaneateles falls, NY 13153 ; 8129310130
• MDR Report Key: 20772359
• Report Number: 1316463-2024-00155
• Device Sequence Number: 15499304
• Product Code: HKO
• UDI-Device Identifier: 00732094212235
• UDI-Public: (01)00732094212235
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/25/2024
• 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