MAUDE Adverse Event Report: WELCH ALLYN INC. VS100 POWER SUPPLY SET/PLUGB/US; REFRACTOMETER, OPTHALMIC

Model Number 106369

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2023

Event Type  malfunction  

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 device was inspected and exposed frayed wires at base of power supply caused by excessive wear and tear were identified.The power supply was replaced to resolve the issue.Based on this information no further actions are required.Although there was no reported injury with this event, if the report of damaged power supply with frayed wires were to recur, it could potentially cause serious injury or death.Therefore hillrom is reporting this event.

Event Description

Customer reported power supply not working.During visual inspection of power supply found exposed frayed wires at base of power supply caused by excessive wear and tear.This incident was captured under hillrom complaint ref (b)(4).

• Brand Name: VS100 POWER SUPPLY SET/PLUGB/US
• Type of Device: REFRACTOMETER, OPTHALMIC
• Manufacturer (Section D): WELCH ALLYN INC.; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17256919
• MDR Text Key: 318562114
• Report Number: 1316463-2023-00153
• Device Sequence Number: 1
• Product Code: HKO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 106369
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1