MAUDE Adverse Event Report: MORTARA INSTRUMENT S4 TRANSMITTER 10-WIRE NO SPO2 GEN2; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number S4-Q-BXX-XXX

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2023

Event Type  malfunction  

Event Description

The customer reported the device was restarting continuously.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

Baxter is in the process of inspecting the surveyor s4 monitor.There was no allegation of patient or caregiver injury or death reported from this alleged incident.Investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.

Event Description

The customer reported the device was restarting continuously.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The surveyor s4 mobile monitor is indicated for use to acquire, analyze and output multi-lead ecg and spo2 signals.The welch allyn surveyor s4 mobile monitor facilitates the monitoring of ecg and spo2 parameters when used in conjunction with alarm annunciating devices such as the surveyor central station for telemetric monitoring.The surveyor s4 processes heart rate, arrhythmias such as, but not limited to, ventricular tachycardia, ventricular fibrillation, heart rate, and st segment deviation by utilizing welch allyn veritastm ecg algorithm.The surveyor s4 can deliver data from a 3/5-lead cable and diagnostic 12-lead ecg data to a receiving surveyor central station.The surveyor s4 mobile monitor is indicated for use as a mobile radio transceiver, allowing the patient to be ambulatory within the range of a wi- fi information infrastructure.The surveyor s4 mobile monitor is indicated for use in adults, adolescents and children.The surveyor s4 mobile monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare or clinical setting.It is not intended as a sole means of diagnosis.Upon inspection, the baxter technician determined that liquid ingress caused the damage of the device.Consequently, oxidations on the device main board, lcd touchscreen failure and sam module connector damage was found.A replacement of the components were sent to the customer.Based on this information, no further actions are required at this time.The instructions for use contains the following safety information: do not immerse the s4 in water or any other fluids.The s4 is not designed to be immersed in liquid and doing so may result in liquid entering the device leading to possible safety hazards and/or device malfunction.Be careful not to use an excessive amount of disinfecting solution that could lead to fluid entering the device.Fluid ingress may cause irreparable damage to the internal circuitry.Do not steam autoclave, gas sterilize, or irradiate the s4 as these may result in damage to the device.Ensure the battery door is securely in place when cleaning the s4 to avoid risk of liquid entering into the device which may lead to a possible hazard and/or device malfunction.Although there was no reported injury with this event, if the report of surveyor s4 restarting continuously during use were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.

• Brand Name: S4 TRANSMITTER 10-WIRE NO SPO2 GEN2
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: daniela avila ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18151594
• MDR Text Key: 329327388
• Report Number: 2183461-2023-00025
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00812345027846
• UDI-Public: 812345027846
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K160685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

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: S4-Q-BXX-XXX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 10/20/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1