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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 Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2021
Event Type  malfunction  
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse) the cardiosave intra-aortic balloon pump (iabp) ecg and pressure connector ports were loose. There was no patient involvement, and no adverse event was reported.
 
Manufacturer Narrative
Fse removed the front end board to tighten the nut on both the ecg and pressure connector ports. When reinserting the frond end board, one of the connection pins was not aligned properly and folded over. When fse tried to straighten it out, it broke off. The fse ordered the front end board and returned to the facility to replaced it. All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service. A supplemental report will be submitted upon completion of our investigation the initial reporter named is a getinge employee whose contact details differ from that of the event site. A contact at the event site is: (b)(6). The full name of the event site in was shortened due to field character limit; the full name is (b)(6).
 
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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
MDR Report Key12707942
MDR Text Key281846817
Report Number2249723-2021-02482
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
Type of Report Initial
Report Date 10/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2021
Is This a Reprocessed and Reused Single-Use Device?

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