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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 Gas/Air Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/02/2020
Event Type  malfunction  
Manufacturer Narrative
A (b)(4) field service engineer (fse) evaluated the iabp and was unable to reproduce the reported issue.The fse tested the helium system, and no leak was noted.The fault logs had two entries of "leak in iab circuit," indicating a leak external to the iabp unit.The fse performed safety disk leak test and k6, k6a, k7 & k8 leak tests, and the iabp unit passed the tests, and no leaks were noted.The fse advised the customer to check the patient circuit.The fse performed a battery run time test, and noted that the battery run time barely passed, so the batteries were replaced.The fse then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.(b)(6).
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) had a helium leak.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.Original description: helium leak.Tech request.Po: pending.(b)(4).Technicians remarks: "helium leak" reported by customer.Tested helium system, no leak noted.Fault logs had two entries of "leak in iab circuit," i= ndicating a leak external to the unit.Perform safety disk leak test and k6, k6a, k7 & k8 leak tests - unit passed tests, no le= s noted.Advise customer to check patient circuit.Noted low battery run time, replaced batteries.Perform all functional, pn= matic and electrical safety tests.Unit passes all tests and is cleared for clinical use.** note: in facility for a demand pm on another unit.
 
Manufacturer Narrative
Updated fields: b4, g4, g7, h2, h6(evaluation method codes), h10.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) had a helium leak.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was 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 Key10936822
MDR Text Key244277173
Report Number2249723-2020-02050
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 02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
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 Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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