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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 Patient Involvement (2645)
Event Date 11/21/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.The stm has advised that a replacement part has been ordered and is pending receipt.The faulty helium regulator assembly has been requested back for further evaluation.A supplemental report will be submitted when additional information is provided.(b)(6).
 
Event Description
It was reported that during repair of the cs300 intra-aortic balloon pump (iabp) performed by a getinge service territory manager (stm), the helium regulator assembly received as a replacement part was observed to be bad and had a slow internal helium leak.This is an out-of-box failure (oobf) of the helium regulator assembly.Since the event occurred during a repair, there was no patient involved and no adverse event was reported.
 
Manufacturer Narrative
The suspected faulty helium regulator assembly was sent to sustaining engineering for evaluation.In an attempt to reproduce the failure, by a senior electronic technician , the helium regulator assembly was leak tested by applying helium pressure to the assembly and using the detector, and no leaks were found.The helium regulator assembly will be discarded as per procedure.
 
Event Description
It was reported that during repair of the cs300 intra-aortic balloon pump (iabp) performed by a getinge service territory manager (stm), the helium regulator assembly received as a replacement part was observed to be bad and had a slow internal helium leak.This is an out-of-box failure (oobf) of the helium regulator assembly.Since the event occurred during a repair, there was no patient involved and no adverse event was 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 Key9490318
MDR Text Key191401704
Report Number2249723-2019-02059
Device Sequence Number1
Product Code DSP
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 05/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 11/21/2019
Initial Date FDA Received12/18/2019
Supplement Dates Manufacturer Received04/26/2020
Supplement Dates FDA Received05/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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