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

Model Number	SCSYS-IED-LBFAX
Medical Device Problem Codes	Device Alarm System (1012); Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A hillrom field service technician visited the customer site and identified that the surveyor central database was corrupted.The field technician rebuilt the surveyor central database, and confirmed that the sound reported by the customer was the surveyor central watchdog producing an alarm to alert the user of the database issue.Based on this information, no further action is required.
Event or Problem Description
The customer reported a malfunction of the surveyor central device which emitted a loud continuous sound, in a subsequent follow-up with the customer they confirmed that the central station was not picking up the telemetry device.The device was in use for continuous patient monitoring, and the customer reported that the malfunction resulted in the patient not being monitored.The customer confirmed that there was no associated patient injury.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: SCS MIX ITA 220V 24SL-24TEL 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: 11857006
• Report Number: 1316463-2021-00012
• Device Sequence Number: 17111014
• Product Code: MHX
• UDI-Device Identifier: 00732094262131
• UDI-Public: 732094262131
• 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): 04/22/2021

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-LBFAX
• 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: 04/22/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1