MAUDE Adverse Event Report: MORTARA INSTRUMENT S19 GEN2 (N)SPO2 4IP IEC AM12M LAN; DETECTOR AND ALARM, ARRHYTHMIA

Model Number	SUR19-XDH-XXXAX
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the s19 unit did not sound an alarm when ventricular fibrillation was detected by the surveyor central with a red alert.This incident was captured under hillrom complaint ref # (b)(4).
Additional Manufacturer Narrative
The surveyor s19 patient monitors are small, lightweight patient monitors designed to acquire physiological waveforms and parameters, and to transmit this data to the surveyor central monitoring station.The bed to bed communication feature allows remote viewing of monitors when connected to a surveyor central station.The welch allyn surveyor patient monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.The baxter technician went on site was not able to identify the cause of the missing sound alarm, there was no issue found with the device and the customer additionally confirmed that in other following occurrences this issue did not happen again and the device alarmed as normal.The situation will continue to be monitored and any relevant additional information received will be submitted in a supplemental report.Based on this information no further actions are required at this time.Although there was no adverse event reported as a result of this incident and the doctor was alerted to the change in morphology by the visual alarm on the control units screen, if an audible alarm not sounding during a red alert were to recur, it could lead to a serious injury or death.Therefore baxter is reporting this malfunction.

• Brand Name: S19 GEN2 (N)SPO2 4IP IEC AM12M LAN
• Common Device Name: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 19583147
• Report Number: 2183461-2024-00017
• Device Sequence Number: 15273774
• Product Code: DSI
• UDI-Device Identifier: 00732094321449
• UDI-Public: 732094321449
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/21/2024

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: SUR19-XDH-XXXAX
• 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: 05/24/2024
• Initial Report FDA Received Date: 06/21/2024
• 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