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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 Problems Device Contamination with Body Fluid (2317); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Arrest (1762)
Event Date 08/16/2019
Event Type  Injury  
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. A getinge field service engineer (fse) was dispatched to investigate the report of a blood back event. Upon evaluation of the iabp, the fse observed blood in the unit and no failure was identified. The fse replaced the following components due to blood contamination: reservoir assembly, purge valve assembly, condensation removal module (crm) english, safety disk assembly english and iabp blood detect tubing. Full functional and safety tests were performed and the iabp unit passed all functional and safety checks per factory specifications. The iabp was returned to the customer and cleared for clinical use. The full name of the initial reporter is (b)(6).
 
Event Description
It was reported by the nurse in the coronary icu that earlier in the day the patient had a cardiac arrest. The staff noted that the intra-aortic balloon (iab) had blood in the helium tubing that may have entered the intra-aortic balloon pump (iabp). The staff removed the iab and pulled the iabp from service. The pump was sent to the biomed without knowledge as to whether service is needed. There was no reported malfunction of the iabp. The iab used during this event has been reported under mfg report number (b)(4).
 
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Brand NameCS300
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key8977626
MDR Text Key158713592
Report Number2249723-2019-01442
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/09/2019 Patient Sequence Number: 1
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