MAUDE Adverse Event Report: WELCH ALLYN INC. SECURING RING, 1934615; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number 408363

Device Problem Defective Component (2292)

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

Event Date 06/06/2023

Event Type  malfunction  

Manufacturer Narrative

The welch allyn gs 900 procedure light is designed to meet the various needs of the physician¿s office, hospital environment and specialist¿s office.It is not intended for rendering diagnosis or surgery.The gs 900 light is mounted on a mobile stand, ceiling mount or wall mount.Upon review of images provided by the customer, it was noted that the spacer tube was damaged along with the securing ring.Replacement parts were sent out to the customer.Based on this information no further actions are required at this time.Although there was no reported injury, if the gs900 ceiling mount was physically damaged and was to fall during a procedure it could lead to serious injury or death.Therefore, hillrom is reporting this malfunction.

Event Description

The customer reported the gs900 lamp has physical damage to the securing ring.It was stated the ring was cracked and the light would not stay on the arm.This incident was captured under hillrom complaint ref # (b)(4).

• Brand Name: SECURING RING, 1934615
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• 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: 17182398
• MDR Text Key: 317809535
• Report Number: 1316463-2023-00139
• Device Sequence Number: 1
• Product Code: KZF
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 408363
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2023
• 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