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

Model Number 106369

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 12/27/2023

Event Type  malfunction  

Event Description

The customer reported the unit would not power on and the power cord had physical damage with copper wires exposed.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

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 cord has not been returned to hillrom for inspection.Therefore, an investigation into the root cause of the reported issue could not be performed.The customer was provided the part number for a replacement cord.Based on this information, no further actions are required at this time.If the unit would not power on it would be obvious to the user.If an alternate device was not available, the user would either reschedule the screening test when a device was available, or if testing could not be delayed, refer the patient to another facility where testing could be performed.Hillrom does not consider reports of a device not powering on to be a reportable malfunction.Although there was no reported injury with this event, if the report of a damaged power supply with exposed copper wires were to recur, it could potentially cause serious injury or death.Therefore hillrom is reporting this event.

• Brand Name: VS100 POWER SUPPLY SET/PLUGB/US
• Type of Device: 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: 18416870
• MDR Text Key: 331582954
• Report Number: 1316463-2023-00269
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 106369
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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