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 Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
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 technician replaced the power cord to resolve the reported event.Based on this information, no further action is required.Although there was no serious injury or death reported, if a frayed power cord with exposed copper wires were to recur, it could result in a serious injury or death.Therefore hillrom is reporting this malfunction.
Event or Problem Description
The customer reported the vs100 would not hold a charge when unplugged.The device was returned for bench repair where the technician determined that the power cord was frayed with exposed wires.This incident was captured under hillrom complaint ref (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 east; skaneateles falls NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17032078
• Report Number: 1316463-2023-00124
• Device Sequence Number: 6516109
• Product Code: HKO
• UDI-Device Identifier: 00732094212228
• UDI-Public: 732094212228
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 05/31/2023

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: 05/09/2023
• Initial Report FDA Received Date: 05/31/2023
• 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