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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 N/A
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 01/28/2021
Event Type  malfunction  
Manufacturer Narrative
During a preventative maintenance (pm) service, the getinge field service engineer (fse) discovered a broken fiber optic connector.To fix the issue, the fse installed a new fiber optic sensor assembly.The fse then performed calibration, all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.The initial reporter named in is a getinge employee who has different contact details from that of the event site, and has the following contact information: (b)(6).The full event site name in is (b)(6).
 
Event Description
It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the fiber optic connector of the cardiosave intra-aortic balloon pump (iabp) was found broken.There was no patient involvement, and no adverse event reported.
 
Event Description
It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the fiber optic connector of the cardiosave intra-aortic balloon pump (iabp) was found broken.There was no patient involvement, and no adverse event reported.
 
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Brand Name
CARDIOSAVE HYBRID TYPE B PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key11345196
MDR Text Key232622041
Report Number2249723-2021-00327
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 company representative
Type of Report Initial,Followup
Report Date 04/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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