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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 Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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.At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.Not returned to manufacturer.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) displayed a high temperature alarm.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 the cardiosave intra-aortic balloon pump (iabp) displayed a high temperature alarm.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.
 
Manufacturer Narrative
Updated fields: b4, e1 (email address), g4, g7, h2, h10, h11.Corrected fields: h3, h6 (evaluation method, result & conclusion code).A getinge field service engineer (fse) was dispatched to evalaute the iabp.The fse reviewed the event/fault logs and did not find anything related to the alarm.The fse ran the diagnostics and performance tests and found that the a/c indicator was constantly flashing and there was no indication of the battery charging.The fse observed that the unit would only run on battery and does not recognize a/c power.The fse suspected the power management board and replaced this pat; however, this did not resolve the issue.The fse then ordered a new power supply and later returned to replave this part.Once replaced, this resolved the d/c power issue.The batteries were now charging again and the diagnostics showed the voltage for the cart.The fse complated all diagnostics, performance and safety tests.The iabp unit passed all tests to factory specifications.The unit was returned to the customer and cleared for clinical use.
 
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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 Key8637131
MDR Text Key146237910
Report Number2249723-2019-00845
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,user f
Type of Report Initial,Followup
Report Date 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2019
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? No
Date Manufacturer Received05/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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