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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-CAL 370 SYSTEM, THERMAL REGULATING

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PERFUSION SYSTEMS BIO-CAL 370 SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 95161-000
Device Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/04/2015
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Medtronic requested additional information regarding the water source and cleaning protocols the facility was using with the bio cal, but no response was received.
 
Event Description
Medtronic received information that during set up prior to use the 370 bio-cal instrument displayed error code 004, indicating a calibration error on probe two. The instrument was changed out with a backup prior to use and there was no patient involvement in the event. The bio cal was returned to the medtronic service depot for repair. Medtronic requested additional information regarding the water source and cleaning protocols the facility was using with the bio cal, but no response was received.
 
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Brand NameBIO-CAL 370
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
Manufacturer (Section G)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key6159289
MDR Text Key101855265
Report Number2184009-2016-00035
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K894980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number95161-000
Device Catalogue Number95161-000
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 Received12/06/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/02/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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