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

Model Number	44900
Medical Device Problem Codes	Fitting Problem (2183); Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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.No further information is available on the device at this time.The device is being returned to the hillrom manufacturer for a thorough investigation.Hillrom will submit a final report with investigation conclusion on this incident.
Event or Problem Description
Customer reported physical damage that occurred on their power cord for their device and a fit issue for the light.The customer states the luminer will not fit on the end of the mobile stand and the power cord appears to be burnt.The device has been requested back and a replacement unit is being sent to the customer.This report was filed in our complaint handling system as complaint #(b)(4).
Additional 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.The customer reported physical damage that occurred on their power cord for their device and a fit issue for the light.The customer states the luminer will not fit on the end of the mobile stand and the power cord appears to be burnt.A clinician would immediately recognize a fit issue if the luminer does not fit correctly and would likely remove it from clinical service until the device is repaired or replaced.If the procedure light were to be unavailable for use, the clinician would obtain an alternative light, which may result in a delay.Such delays are brief and would not result in significant risk to the patient.If a back-up device was unavailable, the patient could be rescheduled or referred to another practice.All welch allyn electrical devices are designed and tested to meet all applicable safety and flammability regulations.Welch allyn's lighting devices are not hand held by the user and therefore decrease the likelihood that the user would sustain a 1st or 2nd degree burn if the device were to become hot.If these burns were to occur, they would generally not be considered serious and would heal without further medical intervention.If a device were to get hot to touch, spark, have burn marks or burned components a trained clinician would not use the device and remove it from the patient's environment.The customer has not returned the device, therefore no further investigation into the root cause of the reported issue could be performed.The customer received a replacement device.Should additional information be provided, a supplemental report will be filed.However, based on the information provided at this time no further action is required.
Event or Problem Description
Customer reported physical damage that occurred on their power cord for their device and a fit issue for the light.The customer states the luminer will not fit on the end of the mobile stand and the power cord appears to be burnt.The device was requested back and a replacement unit is being sent to the customer, however the customer has not returned the device back.This report was filed in our complaint handling system as complaint #(b)(6).

• Brand Name: GS-900 PROC.LT W/MOBILE STD DOM
• Common Device Name: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street road; skaneateles falls NY 13153
• Manufacturer Contact: sarah oreilly ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 12725548
• Report Number: 1316463-2021-00056
• Device Sequence Number: 4639131
• Product Code: KZF
• UDI-Device Identifier: 00732094073362
• UDI-Public: 732094073362
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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
• Device Lot Number: 2112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/31/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown