MAUDE Adverse Event Report: WELCH ALLYN INC. GS-900 PROC.LT W/CEILING MOUNT; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number 44900-C

Device Problem Insufficient Information (3190)

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

Event Date 05/22/2023

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.It is unknown how extensive the physical damage was and how it occurred.The customer has not returned the unit for inspection therefore, a root cause of the reported event could not be determined.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 cautiously reporting this event.Based on the information provided at this time no further action is required.

Event Description

It was reported that the gs900 ceiling mount sustained physical damage to the swing arm.This incident was captured under hillrom complaint ref # (b)(4).

• Brand Name: GS-900 PROC.LT W/CEILING MOUNT
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• 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: 17152345
• MDR Text Key: 317865871
• Report Number: 1316463-2023-00134
• Device Sequence Number: 1
• Product Code: FSR
• UDI-Device Identifier: 00732094004571
• UDI-Public: 732094004571
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2023

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: 44900-C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/19/2023
• 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