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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Overheating of Device (1437); Temperature Problem (3022)
Patient Problem No Patient Involvement (2645)
Event Date 10/23/2020
Event Type  malfunction  
Manufacturer Narrative
The stm replaced the power supply then tested the iabp unit and observed proper function with no overheating issues.The stm completed pm service including all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.The initial reporter named is a getinge employee whose contact details are: email address (b)(6); which differs from that of the event site.
 
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm), the power supply for the cs300 intra-aortic balloon pump (iabp) was overheating.There was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
Updated fields: b4, g4, g7, h2, h6(evaluation method codes), h10, h11.Corrected fields: h6(device codes).
 
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm), the power supply for the cs300 intra-aortic balloon pump (iabp) was overheating.There was no patient involvement, and no adverse event reported.
 
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Brand Name
CS300
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key10853032
MDR Text Key217425150
Report Number2249723-2020-01926
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
Type of Report Initial,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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