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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 Problem Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Date 10/20/2020
Event Type  malfunction  
Manufacturer Narrative
The getinge service territory manager (stm) that encountered the issue replaced the tubing assembly: "tubing, blood detect, iabp".The stm then completed a full calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The iabp was released to the customer and cleared for clinical service.The full name of the event site was shortened due to field character limit; the full name is: (b)(6).The initial reporter named is a getinge employee whose contact details are: (b)(6) which differs from that of the event site.
 
Event Description
It was reported getinge service territory manager (stm) during scheduled service for an unrelated repair.The stm discovered that some of the tubing was showing discoloration and appeared to be cracking in the cs300 intra-aortic balloon pump (iabp).The customer was not aware of this.The issue was not noticed previously and the unit was working with out any report of leaks.Since the event was found during service, there was no patient involvement, and no adverse event reported.
 
Event Description
It was reported getinge service territory manager (stm) during scheduled service for an unrelated repair.The stm discovered that some of the tubing was showing discoloration and appeared to be cracking in the cs300 intra-aortic balloon pump (iabp).The customer was not aware of this.The issue was not noticed previously and the unit was working with out any report of leaks.Since the event was found during service, 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: g3.
 
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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 Key10826223
MDR Text Key216139169
Report Number2249723-2020-01897
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,health
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
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 Received11/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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