• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP STAT PROFILE PRIME PLUS ANALYZER SYSTEM BLOOD GAS ANALYZER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NOVA BIOMEDICAL CORP STAT PROFILE PRIME PLUS ANALYZER SYSTEM BLOOD GAS ANALYZER Back to Search Results
Model Number 57400
Device Problem Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/04/2019
Event Type  malfunction  
Manufacturer Narrative
A nova biomedical field service technician visited the user facility to service the analyzer. They determined that the issue was caused by a calibrator cartridge that was not properly prepared prior to use. The field service technician confirmed that replacing the calibrator cartridge resolved the issue and returned the analyzer to service.
 
Event Description
A user facility reported a nova biomedical prime plus analyzer that showed discrepant creatinine results when compared to their reference analyzer. There was no patient harm or medical intervention reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTAT PROFILE PRIME PLUS ANALYZER SYSTEM
Type of DeviceBLOOD GAS ANALYZER
Manufacturer (Section D)
NOVA BIOMEDICAL CORP
200 prospect st.
waltham MA 02454 3654
Manufacturer (Section G)
NOVA BIOMEDICAL CORP
200 prospect st.
waltham MA 02454 3654
Manufacturer Contact
mariya cesnulevicius
200 prospect st.
waltham, MA 02454-3654
7816473700
MDR Report Key9344974
MDR Text Key190819914
Report Number1219029-2019-00072
Device Sequence Number1
Product Code CGL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number57400
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2019
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

-
-