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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOE MEDICAL, INC. ULTRAVIEW; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
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ZOE MEDICAL, INC. ULTRAVIEW; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number 90369
Device Problems Device Sensing Problem (2917); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2021
Event Type  malfunction  
Event Description
On a new neonate admit, the cuff blood pressure (bp) quit working and the massimo pulse ox was not transferring to the space labs.As a result, the sats were not relaying to the central monitor.Biomed had to come troubleshoot to fix it.It required switching out the entire massimo.No patient harm.In-house biomed follow up: spacelabs monitor 90369: customer reported bp not working and spo2 reading not transferring from masimo dock.Ran functional bp tests, unsuccessful.Changed bp hose and successfully passed tests.Switched masimo docks and was unsuccessful in transferring reading.Switched spacelabs monitors with empty bedspace and successfully transferred masimo spo2 reading.Verified proper operation and returned to service.
 
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Brand Name
ULTRAVIEW
Type of Device
SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
ZOE MEDICAL, INC.
460 boston st.
topsfield MA 01983
MDR Report Key11588161
MDR Text Key242913254
Report Number11588161
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/26/2021,03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number90369
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/26/2021
Event Location Hospital
Date Report to Manufacturer03/30/2021
Type of Device Usage Unknown
Patient Sequence Number1
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