MAUDE Adverse Event Report: WELCH ALLYN, INC. SCS MIX ITA 220V 24SL-16TEL 600D FD; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	SCSYS-IED-KBFAX
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service technician visited the customer site on the 28th april 2021.The technician rebooted the pc and also reinstalled the software which did not resolve the issue.The technician then modified the multicastconfig parameter in the host file, which resolved the malfunction.Based on this information, no further action is required.
Event or Problem Description
A customer reported a malfunction with their surveyor central device.They reported that the process that manages the display of the central user interface was repeatedly crashing and restarting.Subsequently the device could not be restarted at all, leaving the user without the patient monitoring visualization.A review of the device log files by a hillrom technician identified that the issue began on the 26th april 2021.The customer's surveyor central system was composed of a single node, connected to 6 s12 bedside monitors and 18 s4 telemetries.The device was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint (b)(4).

• Brand Name: SCS MIX ITA 220V 24SL-16TEL 600D FD
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street road; skaneateles falls NY 13153
• MDR Report Key: 11826578
• Report Number: 1316463-2021-00011
• Device Sequence Number: 3535273
• Product Code: MHX
• UDI-Device Identifier: 00732094262148
• UDI-Public: 732094262148
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K131929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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
• Operator of Device: No Information
• Device Model Number: SCSYS-IED-KBFAX
• 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: 04/27/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1