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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-UC-3013-53
Device Problem Display or Visual Feedback Problem (1184)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/23/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse confirmed the iabp need replacement of the display pcb and video receiver pcb.Additional information has been requested, and we will report accordingly if it becomes available.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) display is flickering.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
 
Event Description
It was reported that prior to use the cs300 intra-aortic balloon pump (iabp) display was flickering.There was no patient involvement and no adverse event was reported.
 
Manufacturer Narrative
Updated fields: a1, b4, b5, e2, e3, g3, g6, h2, h6 (health effect clinical code, type of investigation, component codes, health effect impact codes, investigation conclusions), h10.A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse was unable to reproduce the issue.However the display panel and video receiver were replaced.The iabp unit was cleared for clinical use and released to the customer.
 
Manufacturer Narrative
The getinge field service engineer (fse) who evaluated the unit reported that the problem had been rectified by replacing the display panel and video receiver pcb.It is unknown if the unit has been returned to the customer and cleared for clinical use.A supplemental report will be submitted if this information is provided to us.
 
Event Description
It was reported that the cs100 intra-aortic balloon pump (iabp) display is flickering.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
 
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Brand Name
CS100
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key10852847
MDR Text Key217423522
Report Number2249723-2020-01924
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107745
UDI-Public10607567107745
Combination Product (y/n)N
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 03/23/2021
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 Catalogue Number0998-UC-3013-53
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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