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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP - UTS, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP - UTS, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-83
Device Problem Break (1069)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/15/2022
Event Type  malfunction  
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had a cracked screen.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.
 
Manufacturer Narrative
The initial reporter¿s name is shortened due to field character limit.The full name is (b)(6).Type of investigation not yet determined: a supplemental report will be submitted upon receipt of additional information.
 
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Brand Name
CS300 INTRA-AORTIC BALLOON PUMP - UTS, 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
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key13772640
MDR Text Key289440135
Report Number2249723-2022-00528
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108285
UDI-Public10607567108285
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0998-00-3023-83
Device Catalogue Number0998-00-3023-83
Device Lot NumberN/A
Date Manufacturer Received02/15/2022
Was Device Evaluated by Manufacturer? No
Type of Device Usage Reuse
Patient Sequence Number1
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