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

Model Number	VS100S-B
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.There was no allegation of patient or caregiver injury or death reported from this alleged incident.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
Event or Problem Description
The customer reported that the vs100 power cord was frayed.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
Event or Problem Description
The customer reported that the vs100 power cord was frayed.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
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.Baxter has contacted the account three times requesting the device to be returned for inspection.The account was unresponsive to the attempts and the device did not return to manufacture.Thus, baxter is completing this complaint due to the amount of time.Based on this information, no further action is required.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.

• 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
• MDR Report Key: 20333363
• Report Number: 1316463-2024-00124
• Device Sequence Number: 8097378
• Product Code: HKO
• UDI-Device Identifier: 00732094212228
• UDI-Public: (01)00732094212228(11)211103
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 11/12/2024

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
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2021
• 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