MAUDE Adverse Event Report: WELCH ALLYN, INC. PROCEDURE HDLT W/DIRECT PS-DOM; LIGHT, HEADBAND, SURGICAL

Model Number	49020
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the procedure headlight sparked while the user was wearing the device.The procedure headlight was plugged into a battery pack when visible sparks were noted on the outside of the device.There was no injury or burn to the user or patient.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The customer reported the procedure headlight sparked while the user was wearing the device.The procedure headlight was plugged into a battery pack when visible sparks were noted on the outside of the device.There was no injury or burn to the user or patient.This headlight is designed to meet the various needs of the physician¿s office, hospital environment, and specialist¿s office.Although this event did not result in injury to the user or patient, the reported malfunction of the headlight sparking while in use could contribute to a serious injury or death if it were to recur.Additionally, if the reported event were to occur in an oxygen rich environment, the risk of ignition and fire significantly increases.The ifu does however state a warning green series procedure headlight is not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide.An explosion may result.Therefore, hillrom considers this complaint a reportable malfunction.Based on this information, no further action is required.

• Brand Name: PROCEDURE HDLT W/DIRECT PS-DOM
• Common Device Name: LIGHT, HEADBAND, SURGICAL
• 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: 13594137
• Report Number: 1316463-2022-00015
• Device Sequence Number: 14670240
• Product Code: FSR
• UDI-Device Identifier: 00732094072174
• UDI-Public: 732094072174
• Combination Product (Y/N): N
• PMA/510(K) Number: K031548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

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: 49020
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/24/2022
• 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