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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID DOMESTIC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53
Device Problem Failure to Charge (1085)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
Event Type  malfunction  
Manufacturer Narrative
The full name of the event site was shortened due to field character limit; the full name is (b)(6) medical center. Testing of actual/suspected device: a getinge field service engineer (fse) called the customer to discuss the issue and found that it was not a service issue. The console was not fully seated in the cart, causing the unit to run in rescue mode. In rescue mode the unit does not charge the batteries. The fse had them seat the console properly into the cart, and the unit proceeded to charge. The fse verified with the customer that the batteries had fully charged overnight. No issue and no onsite service required. A supplemental report will be submitted if this information is provided to us.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) batteries would not charge. It is unknown the circumstances under which the event occurred. However, there was no patient involvement, and no adverse event reported.
 
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Brand NameCARDIOSAVE HYBRID DOMESTIC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12281709
MDR Text Key265195189
Report Number2249723-2021-01728
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,user f
Reporter Occupation
Type of Report Initial
Report Date 08/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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