MAUDE Adverse Event Report: MORTARA INSTRUMENT SURVEYORCENTRAL-RO; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	SURVEYORCENTRAL-RO
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hillrom is in the process of arranging a site visit to inspect the surveyor central system.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 or Problem Description
The customer reported that the surveyor central has intermittent connectivity issues, and it alarms continuously once restarted.This report was filed in our complaint handling system as (b)(4).
Additional Manufacturer Narrative
Hillrom attempted to arrange a site visit to inspect the surveyor central system however the customer informed us that the device no longer needs repair.Issue was resolved by the customer.Therefore no investigation into the reported malfunction could be performed.There was no serious incident reported and should this malfunction recur, it is unlikely to cause or contribute to a serious incident for the reasons stated above.Therefore, hillrom does not consider this complaint reportable.
Event or Problem Description
The customer reported that the surveyor central has intermittent connectivity issues, and it alarms continuously once restarted.This report was filed in our complaint handling system as (b)(4).

• Brand Name: SURVEYORCENTRAL-RO
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: frances ccote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16830086
• Report Number: 2183461-2023-00010
• Device Sequence Number: 1931655
• Product Code: MHX
• UDI-Device Identifier: 00732094262735
• UDI-Public: 732094262735
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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: SURVEYORCENTRAL-RO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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