MAUDE Adverse Event Report: WELCH ALLYN INC. PROF. GS 777 INT'D DIAG SYS UK; STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC

Model Number	77744
Medical Device Problem Codes	Power Problem (3010); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The gs 777 wall transformer product is intended to supply power to welch allyn 3.5v instruments.No further information is available on the device at this time.Hillrom has requested for the device to be returned for analysis, once a complete investigation has been performed on the device a final report will be submitted with hillroms findings.
Event or Problem Description
Customer reported that the green series gs 777 wall transformer started to spark and burn when the mains plug was plugged in to the wall socket.It was additionally reported that there was burn damage caused to the plug as a result.There was no reported injury.This report was filed in our complaint handling system as complaint (b)(4).
Additional Manufacturer Narrative
Welch allyn diagnostic sets help physicians perform fast physical exams and accurately diagnose a range of patient conditions thanks to innovative optical technologies that help clinicians get wider views of the optic disc and tympanic membrane.The device was returned for investigation.The hrc technician determined that the device failed visual inspection the reported problem of blackened transformer was verified and it was determined that the problem was with the power supply, the power supply was replaced, device was cleaned and a functional check was performed before returning to the customer.However, the power supply was discarded and therefore root cause of the failure of the power supply could not be confirmed.There was no patient impact or injury reported however as the root cause of the power supply failure could not be confirmed and the issue of this complaint is as described in the ongoing fsca with hillrom reference mod1329.Hillrom is cautiously reporting this event.
Event or Problem Description
Customer reported that the green series gs 777 wall transformer started to spark and burn when the mains plug was plugged in to the wall socket.It was additionally reported that there was burn damage caused to the plug as a result.There was no reported injury.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: PROF. GS 777 INT'D DIAG SYS UK
• Common Device Name: STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC
• Manufacturer (Section D): WELCH ALLYN INC.; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 14050471
• Report Number: 1316463-2022-00040
• Device Sequence Number: 17534794
• Product Code: HMF
• UDI-Device Identifier: 00732094136760
• UDI-Public: 732094136760
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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: 77744
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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