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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO CONSOLE 560; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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PERFUSION SYSTEMS BIO CONSOLE 560; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 560BCS1
Device Problem Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/14/2023
Event Type  malfunction  
Event Description
Medtronic received information that prior to use of a bio-console 560 instrument, it was reported that the instrument shut down when the power input was off.The use of the instrument was unspecified.There was no adverse patient effect reported with this event.Medtronic received additional information that it is unknown how long the battery has been installed in the instrument and the lot number of the battery that was removed from the instrument is unknown as there is no service record.
 
Manufacturer Narrative
Device evaluation summary: the reported issue of the instrument shutting down when the power input was off, was verified during service.The issue was resolved by replacing the battery.Preventive maintenance was performed per specifications.Note: the instrument was analyzed/serviced in the facility by a field service technician.The instrument did not return to a medtronic facility for service.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Manufacturer Narrative
Correction b5: medtronic received information that prior to use of a bio-console 560 instrument, it was reported that the instrument shut down when the power input was off.The instrument was replaced.There was no patient involvement, so no adverse effect occurred medtronic received additional information that it is unknown how long the battery has been installed in the instrument and the lot number of the battery that was removed from the instrument is unknown as there is no service record.Correction c: imf code updated.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
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Brand Name
BIO CONSOLE 560
Type of Device
CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key19069262
MDR Text Key340575160
Report Number2184009-2024-00157
Device Sequence Number1
Product Code DWA
UDI-Device Identifier00763000236526
UDI-Public00763000236526
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K080824
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/01/2024
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 Operator Health Professional
Device Model Number560BCS1
Device Catalogue Number560BCS1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/14/2023
Initial Date FDA Received04/09/2024
Supplement Dates Manufacturer Received04/15/2024
Supplement Dates FDA Received05/01/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/04/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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