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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Inability to Auto-Fill (1044)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/28/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp unit and reported that the device displayed an autofill failure error when the device was first turned on.It was seen that it gave an error when tried with catheter.After all the tests were done, it was operated again with the trainer simulator at different ecg values.The device was tested in semi-auto and internally several times.Subsequently, the unit was turned off and on again and re-run at the same ecg values.The device did not fail again.The iabp was delivered to the customer in working condition.(b)(6).
 
Event Description
It was reported that the cs100 intra-aortic balloon pump (iabp) displayed an auto failure error when first turned on.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
 
Event Description
It was reported that the cs100 intra-aortic balloon pump (iabp) displayed an auto failure error when first turned on.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
 
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Brand Name
CS100
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key11204732
MDR Text Key227930099
Report Number2249723-2021-00111
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107394
UDI-Public10607567107394
Combination Product (y/n)N
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-3013-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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