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

Model Number 77744

Device Problems Power Problem (3010); Insufficient Information (3190)

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

Event Date 01/18/2022

Event Type  malfunction  

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.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 Description

The 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 complaint has been captured under hillrom ref # c-(b)(4).

Event Description

The 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 event has been captured in hillroms complaint handling system under ref #(b)(4).

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.

• Brand Name: PROF. GS 777 INT'D DIAG SYS UK
• Type of Device: STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC
• Manufacturer (Section D): WELCH ALLYN INC.; 4341 states street; skaneateles falls NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 14050386
• MDR Text Key: 290151110
• Report Number: 1316463-2022-00035
• Device Sequence Number: 1
• Product Code: HMF
• UDI-Device Identifier: 00732094136760
• UDI-Public: 732094136760
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• 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
• Date Manufacturer Received: 03/10/2022
• 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