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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3013-53
Device Problem No Display/Image (1183)
Patient Problem Insufficient Information (4580)
Event Date 08/30/2023
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that, the cs300 intra-aortic balloon pump (iabp) unit' screen is white.
 
Event Description
N/a.
 
Manufacturer Narrative
A getinge fse evaluated the unit and was able to reproduce the reported issue.The fse reported that, upon initial start up the screen turns white after a few seconds the screen starts working properly.The fse disassembled the unit removed and replaced display and reassembled.The fse verified the display was working properly and recycled the power on and off multiple times.The issue was resolved.The fse then performed a full pm functional check and the unit has passed all test and calibration verifications and was returned to the customer and cleared for clinical use.
 
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Brand Name
CS100 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 Key17702961
MDR Text Key322886714
Report Number2249723-2023-03965
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107394
UDI-Public10607567107394
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/08/2023
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 Health Professional
Device Model Number0998-00-3013-53
Device Catalogue Number0998-00-3013-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/30/2023
Initial Date FDA Received09/07/2023
Supplement Dates Manufacturer Received10/30/2023
11/08/2023
Supplement Dates FDA Received11/01/2023
11/08/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
UNKNOWN.
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