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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVEHYBRID INT TYPE E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVEHYBRID INT TYPE E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-55
Device Problem Failure to Charge (1085)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/21/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit. The fse confirmed the issue. The fse determined the customer did not connect it to the mains long enough while the iabp was not in use. The batteries were replaced. A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported that during a routine check, the batteries of the cardiosave intra-aortic balloon pump (iabp) would not charge. There was no patient involvement, and no adverse event reported.
 
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Brand NameCARDIOSAVEHYBRID INT TYPE E/F PLUG
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
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12009305
MDR Text Key256507036
Report Number2249723-2021-01265
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-55
Device Catalogue Number0998-00-0800-55
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2018
Is the Device Single Use? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/16/2021 Patient Sequence Number: 1
Treatment
UNKNOWN.
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