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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 Problems Display or Visual Feedback Problem (1184); Audible Prompt/Feedback Problem (4020)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 04/09/2020
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge service territory manager (stm) was dispatched to evaluate the iabp and discovered error codes 111 and 112 in the fault logs.To resolve the issue, the stm replaced the backplane board.The stm performed full calibration, functional, and safety checks and unit passed to meet factory specifications.The unit was returned to the customer and cleared for clinical use.
 
Event Description
It was reported by the customer at the cardiosave intra-aortic balloon pump (iabp) displayed a high pitch alarm and the screen froze.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.
 
Event Description
It was reported by the customer that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) displayed a high pitch alarm and the screen froze.It is unknown if there was any patient harm or injury; however there was 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 Key10013611
MDR Text Key193128115
Report Number2249723-2020-00689
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,health
Type of Report Initial,Followup
Report Date 06/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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