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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 NameCS300 INTRA-AORTIC BALLOON PUMP - UTS, ENGLISH, 110V
Type of DeviceSYSTEM, 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
Type of Report Initial
Report Date 03/15/2022
1 Device was Involved in the Event
0 Patients were 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
Device Model Number0998-00-3023-83
Device Catalogue Number0998-00-3023-83
Device Lot NumberN/A
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received02/15/2022
Was Device Evaluated by Manufacturer? No
Type of Device Usage Reuse

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