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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 Failure to Run on Battery (1466)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device (10/3233): during preventative maintenance (pm) conducted by a field service engineer (fse), the batteries were replaced.The pm was completed with full calibration.The unit passed all functional and safety tests to factory specifications.The unit was cleared for clinical use.The initial reporter named is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).
 
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse) the cs300 intra-aortic balloon pump (iabp) failed the battery run time test.There was no patient involvement, and no adverse event was reported.
 
Manufacturer Narrative
It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse) the cs300 intra-aortic balloon pump (iabp) failed the battery run time test.Battery runtime of 50 minutes.Minimum runtime spec is 135 minutes.Replaced batteries(d146-00-0039).Complete checkout and checklist has been performed on s0#43978020 there was no patient involvement, and no adverse event was reported.
 
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 Key14088006
MDR Text Key289115471
Report Number2249723-2022-00809
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107882
UDI-Public10607567107882
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2022
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 NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2010
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
N/A.
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