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

Model Number 106369

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

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

Event Date 05/04/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to hillrom for repair.Investigation is ongoing, any findings will be submitted in a supplementary report.

Event Description

The customer reported the power cord was frayed with exposed wires.This incident was captured under hillrom complaint ref # (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 supply was received by hillrom along with the power cord.Upon inspection it was determined that the power cord was in good working condition with no visible signs of damage.The hrc technician noted that the rubber coating had come loose from the wires at the end of the power supply where the power jack resides.The cause of the damage could not be confirmed.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 hillrom is reporting this event.

Event Description

The customer reported the power cord was frayed with exposed wires.This incident was captured under hillrom complaint ref # (b)(4).

• 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: 17049087
• MDR Text Key: 316389634
• Report Number: 1316463-2023-00125
• 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,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 106369
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2023
• 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