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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-0800-55
Device Problem Temperature Problem (3022)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Additional information has been requested, and we will report accordingly if it becomes available.Not returned to manufacturer.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) was overheating.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was overheating.No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse was unable to reproduce the issue.The fse completed all safety, functionality and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.
 
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Brand Name
CARDIOSAVE HYBRID INT TYPE E/F PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key10853739
MDR Text Key217425121
Report Number2249723-2020-01928
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108414
UDI-Public10607567108414
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,foreig
Type of Report Initial,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0998-00-0800-55
Was Device Available for Evaluation? No
Date Manufacturer Received01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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