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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

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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 11/04/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) spoke with the facility's biomedical engineer (biomed) and asked the biomed if the charging indicator was lit, the biomed said that it was not. The fse then asked the biomed to pull on the unit to make sure that it was latched in the cart correctly. He stated that when he tried the unit, it pulled almost all the way out. This showed that the unit was not inserted fully into the cart. The fse asked the biomed to fully insert the unit into the cart and see if the charging indicator was on. Once the biomed inserted the cart fully the charging indicator light did light up. The fse asked the biomed to keep the unit plugged in overnight and to notify if the batteries charged. The fse spoke to the biomed the following day and the batteries were fully charged. The iabp was returned to the user for clinical use. A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) unit battery will 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, 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
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12858273
MDR Text Key285623228
Report Number2249723-2021-02721
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2021
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? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2016
Is the Device Single Use? No
Type of Device Usage Reuse

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