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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-45
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2021
Event Type  malfunction  
Event Description
It was reported that before use the cardiosave intra-aortic balloon pump (iabp) could not be turned on by pressing the power switch, and the lithium battery could not be charged. There was no patient involvement, and no adverse event was reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit. Fse found that the iabp console was not connected to the cart and the ac power could not be connected as well as the battery could not be charged. The iabp console was reinserted into the cart and the machine was normal and without malfunction. The iabp unit was cleared for clinical use and released to the customer. A supplemental report will be submitted when additional information is provided. (b)(6).
 
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Brand NameCARDIOSAVE HYBRID, TYPE I PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
MDR Report Key12586423
MDR Text Key281147169
Report Number2249723-2021-02276
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0998-00-0800-45
Device Catalogue Number0998-00-0800-45
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
Is This a Reprocessed and Reused Single-Use Device?

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