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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 09/20/2018
Event Type  Death  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided.There was no alleged malfunction of the iabp.However, if additional information is provided, we will submit a supplemental report.
 
Event Description
It was reported that after four days of patient therapy on the cs100 intra-aortic balloon pump (iabp), the iabp alarmed "rapid gas loss" and blood was found in the catheter tubing.The intra-aortic balloon catheter (iabc) was removed.The physician has stated that iabp therapy did not cause harm to the patient.However, the patient died 24 hours post iabc removal.Indications for use was cardiogenic myocardial infarction.There was no reported malfunction of the iabp and the patient's death has not been attributed to the iabp.Please refer to related balloon medwatch report #2248146-2018-00591.
 
Event Description
It was reported that after four days of patient therapy on the cs100 intra-aortic balloon pump (iabp), the iabp alarmed "rapid gas loss" and blood was found in the catheter tubing.The intra-aortic balloon catheter (iabc) was removed.The physician has stated that iabp therapy did not cause harm to the patient.However, the patient died 24 hours post iabc removal.Indications for use was cardiogenic myocardial infarction.There was no reported malfunction of the iabp and the patient's death has not been attributed to the iabp.Please refer to related balloon medwatch report #2248146-2018-00591.
 
Manufacturer Narrative
The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed.There were no non-conformances in the production dhr related to the reported event.
 
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Brand Name
CS100
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key8030369
MDR Text Key126531159
Report Number2249723-2018-01893
Device Sequence Number1
Product Code DSP
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
Report Date 05/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-3013-45
Device Lot NumberN/A
Was Device Available for Evaluation? No
Device Age YR
Date Manufacturer Received04/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LINEAR 7.5FR.34CCSERIALL #: (B)(4); LINEAR 7.5FR.34CCSERIALL #: (B)(4)
Patient Outcome(s) Death;
Patient Age79 YR
Patient Weight63
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