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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-53
Device Problem Premature Discharge of Battery (1057)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2023
Event Type  malfunction  
Event Description
It was reported that, the cs300 intra-aortic balloon pump (iabp) batteries failed to meet runtime spec.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Manufacturer Narrative
Corrected data: b5, b6, b7, d5, e1(name and email), e2, e3, e4, d10, h6 (clinical and impact code).Updated data: b4, g3, g6, h2, h10, h11.
 
Event Description
It was reported that during preventative maintenance testing performed by a getinge field service engineer (gfse), the cs300 intra-aortic balloon pump (iabp) batteries failed to meet runtime specification.There was no patient involvement.
 
Manufacturer Narrative
The getinge field service engineer(fse) evaluated the device for the discovered issue.The fse replaced the batteries and completed a full pm.Full pm, calibration, safety, and functionality checks were completed per the service manual and passed to factory specifications.The device was returned to the customer and released for clinical service.
 
Event Description
N/a.
 
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Brand Name
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key17691609
MDR Text Key322748354
Report Number2249723-2023-03926
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107882
UDI-Public10607567107882
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 12/22/2023
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 Other
Device Model Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Device Lot Number10607567107882
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/25/2023
Initial Date FDA Received09/06/2023
Supplement Dates Manufacturer Received09/11/2023
12/21/2023
Supplement Dates FDA Received09/13/2023
12/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2002
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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