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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ 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 Type  malfunction  
Event Description
It was reported that during a routine check performed by the customer they observed that the cardiosave intra-aortic balloon pump (iabp) had a battery that was not charging. There was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
Testing of actual/suspected device : a getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the iabp unit and advised that the power management board was broken; the customer has been quoted on the replacement parts. Repairs are pending approval. A supplemental report will be submitted if additional information is provided. The full event site name in is (b)(6). The full name of the initial reporter that is abbreviated in is (b)(6).
 
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Brand NameCARDIOSAVE HYBRID W/ 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 Key13505731
MDR Text Key285404537
Report Number2249723-2022-00264
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108414
UDI-Public10607567108414
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2022
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? Yes
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse

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