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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MOTOR EXTERNAL DRIVE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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MEDTRONIC, INC. MOTOR EXTERNAL DRIVE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 560A
Device Problems Pumping Problem (3016); Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
Event Type  Injury  
Manufacturer Narrative
Field service was performed on (b)(6) 2021, instrument not returned to medtronic facility. The reported motor external drive noise issue and customer thought the pump decoupled complaint was not verified during service. Instrument performed as designed and proper operation was verified. Preventive maintenance was performed per specification. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use this bio-console motor external drive had a noise and the customer thought the pump decoupled. The nurses were hand cranking when the perfusionist arrived. The instrument was changed out with a backup and there was no resulting adverse patient effect.
 
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Brand NameMOTOR EXTERNAL DRIVE
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12015286
MDR Text Key256666801
Report Number2182208-2021-02453
Device Sequence Number1
Product Code DWA
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 health professional,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
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 Manufacturer06/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/17/2021 Patient Sequence Number: 1
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