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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR INTRA-AORTIC BALLOON PUMP

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DATASCOPE CORP. SENSATION 7FR INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number 0684-00-0469-01U
Device Problem Difficult to Insert (1316)
Patient Problem No Code Available (3191)
Event Date 05/28/2016
Event Type  malfunction  
Event Description
Iabp balloon failed to hold negative pressure, could not be inserted through sheath.
 
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Brand NameSENSATION 7FR
Type of DeviceINTRA-AORTIC BALLOON PUMP
Manufacturer (Section D)
DATASCOPE CORP.
fairfield NJ 07004
MDR Report Key5764636
MDR Text Key48734549
Report NumberMW5063188
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/13/2018
Device Catalogue Number0684-00-0469-01U
Device Lot Number3000016155
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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