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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS MOTOR EXTERNAL DRIVE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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PERFUSION SYSTEMS MOTOR EXTERNAL DRIVE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 560A
Device Problem Pumping Stopped (1503)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/23/2019
Event Type  Injury  
Manufacturer Narrative
Product has not been returned for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use this bio-console external drive motor instrument had a motor head failure. Instrument was replaced with a backup and there is no reported adverse patient effect. The handcrank was used during the transition to a new motor.
 
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Brand NameMOTOR EXTERNAL DRIVE
Type of DeviceCONTROL, 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
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key9449652
MDR Text Key170214980
Report Number2184009-2019-00080
Device Sequence Number1
Product Code DWA
UDI-Device Identifier00613994647832
UDI-Public00613994647832
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100631
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician Assistant
Type of Report Initial,Followup,Followup
Report Date 02/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number560A
Device Catalogue Number560A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/11/2019 Patient Sequence Number: 1
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