MAUDE Adverse Event Report: MORTARA INSTRUMENT S12 GEN2 (N)SPO2 0IP AHA PRTR LAN; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	SUR12-UAA-XXAAX
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that three s12 devices would not connect or remain connected to the surveyor central.There is no allegation of injury or death.A hillrom service technician will be going on site to investigate and resolve the issue.Hillrom is investigating this issue, and will report back with findings with a final report.
Event or Problem Description
Hillrom received a report from the customer that three s12 devices would either not connect or would have intermittent connection to the surveyor central.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The customer reported that three s12 devices would not connect or remain connected to the surveyor central.There is no allegation of injury or death.A hillrom service technician went on site to investigate the issue.The technician found that the usb cable watchdog was plugged into the incorrect usb port.The technician plugged the device into the correct usb port to resolve the issue.
Event or Problem Description
Hillrom received a report from the customer that three s12 devices would either not connect or would have intermittent connection to the surveyor central.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: S12 GEN2 (N)SPO2 0IP AHA PRTR LAN
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• MDR Report Key: 11842098
• Report Number: 2183461-2021-00006
• Device Sequence Number: 4043606
• Product Code: MHX
• UDI-Device Identifier: 00812345028416
• UDI-Public: 812345028416
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 06/07/2021

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: SUR12-UAA-XXAAX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1