• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG 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 04/07/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp unit and was not able to duplicate the reported issue. The fse verified battery bay operation checks and battery run time test (90min per battery) passed. Battery/ac charging indicator also was functioning correctly on the hospital cart. In addition, the fse replaced power management board as a precautionary measure. Complete pm and performed a full calibration. Unit passed all functional and safety tests per factory specifications. The iabp was returned to customer and cleared for clinical use.
 
Event Description
It was reported that during use on a patient, the batteries in the cardiosave intra-aortic balloon pump (iabp) will not charge. The customer stated that unit recognizes ac power and batteries but they do not get charged. System continued to function on ac power only. The iabp was swapped out because the it is due for preventive maintenance. There was no harm or injury to the patient and no adverse event was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCARDIOSAVE HYBRID TYPE B 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 Key11752009
MDR Text Key248188288
Report Number2249723-2021-00909
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 Other,Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2017
Is the Device Single Use? No
Type of Device Usage Reuse

-
-