MAUDE Adverse Event Report: WELCH ALLYN, INC. 3.5V RECHG F/O LARYNGO HANDLE; LARYNGOSCOPE

Model Number	60835
Medical Device Problem Codes	Sparking (2595); Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that they slid out the battery in laryngoscope handle and a small spark appeared and then a small flame.There was no reported patient involvement or injury.This was an out of box failure.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
Hillrom is awaiting the return of the device for a thorough analysis.Hillrom will submit a final report with investigation conclusion on this incident.
Additional Manufacturer Narrative
The fiber optic laryngoscope handle is an accessory used with compatible rigid fiber optic laryngoscope blades which are used to examine and visualize a patient¿s airway and aid placement of a tracheal tube.Hillrom has requested the device to be returned for analysis however, its location is currently unknown.If the device is received, a thorough investigation will be performed, and the results will be submitted in a supplemental report.
Event or Problem Description
Customer reported that they slid out the battery in laryngoscope handle and a small spark appeared and then a small flame.There was no reported patient involvement or injury.This was an out of box failure.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: 3.5V RECHG F/O LARYNGO HANDLE
• Common Device Name: LARYNGOSCOPE
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street road; skaneateles falls NY 13153
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15401964
• Report Number: 1316463-2022-00126
• Device Sequence Number: 6216728
• Product Code: CCW
• UDI-Device Identifier: 00732094142846
• UDI-Public: 732094142846
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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: 60835
• Was Device Available for Evaluation?: Yes
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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