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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 04/30/2020
Event Type  Injury  
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 reported malfunction of the involved iabp, and the model and serial number was not provided to us. In addition, a getinge representative has advised that the iabp therapy was initiated for the treatment of reduction in blood pressure and that no anomalies or malfunction was found on the iabp unit. No repair for the iabp unit is not required, and the iabp unit is being used currently and normally at this facility. No further investigation is required. Not returned to manufacturer.
 
Event Description
It was reported that during intra-aortic balloon pump (iabp) therapy which was initiated on (b)(6) 2020, the iabp console generated a "gas loss in iab circuit" alarm and blood leakage was observed within the intra-aortic balloon catheter (iabc) on (b)(6) 2020. On (b)(6) 2020 the iabc was removed from the patient; however, after removal of this iabc, the patient's blood pressure was decreased temporarily. Later on, the blood pressure became stable. There was no information available about how long it took for the patient's blood pressure to be stable or whether the patient the decreased blood pressure was treated with a vasopressor agent. However, the iabp therapy ended without using a second iabc. There was no reported malfunction of the iabp and the drop in the blood pressure is not attributed to the iabp as the patient's bp dropped post iabp therapy. Refer to mfg report number 2248146-2020-00261for information on the involved iabc.
 
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Brand NameCARDIOSAVE HYBRID
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
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10118897
MDR Text Key195267859
Report Number2249723-2020-00854
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-45
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received07/28/2020
Was Device Evaluated by Manufacturer? No
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: 06/04/2020 Patient Sequence Number: 1
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