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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 Inability to Auto-Fill (1044)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/09/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit cannot be reviewed per getinge standard operation procedure since the serial number for the unit was not provided.At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested from the customer with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.
 
Event Description
It was reported that during use on a patient in the ccu, the cs300 intra-aortic balloon pump (iabp) read autofill failure after a new intra-aortic balloon (iab) was placed.The tank was reported as open and full and no kinks were noted in the tubing.A second iabp was utilized and there were no problems starting this one.The first iabp was taken out of service and sent to the hospital's biomed department.
 
Event Description
It was reported that during use on a patient in the ccu, the cs300 intra-aortic balloon pump (iabp) read autofill failure after a new intra-aortic balloon (iab) was placed.The tank was reported as open and full and no kinks were noted in the tubing.A second iabp was utilized and there were no problems starting this one.The first iabp was taken out of service and sent to the hospital's biomed department.
 
Manufacturer Narrative
Three (3) good faith efforts (gfes) to obtain the relevant repair and iabp status related to this complaint issue were made to the customer.However, despite our best efforts, customer has not responded to any of our gfes.If additional information is provided, we will submit a supplemental report.
 
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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 Key9537049
MDR Text Key190777140
Report Number2249723-2019-02131
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,health
Type of Report Initial,Followup
Report Date 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received06/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight42
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