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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Leak/Splash (1354)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit cannot be reviewed per getinge standard operationg procedure since the serial number for the unit was not provided. There has been no request for service by the customer. This was a generic complaint collected as part of an anonymous survey. A supplemental report will be sent if additional information is provided. (b)(6) medical ctr. Not returned to manufacturer.
 
Event Description
As part of the iabp recall relating to use, care and maintenance, the cardiac assist clinical team collects survey information from customers post training. One such survey listed the following comment: the only issue we have is the helium leakage. From the tank/valve connection. Need better washers. The survey is anonymous so the identity of the person who submitted this complaint is unknown. It is unknown the circumstances in which the event occurred and also unknown if there was patient involvement. There was no adverse event reported.
 
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Brand NameCARDIOSAVE
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 Key9760731
MDR Text Key185570200
Report Number2249723-2020-00328
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 02/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-45
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2020
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

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