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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE I PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE I PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-45
Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/28/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge authorized dealer field service engineer (fse) was dispatched to investigate.The fse evaluated the unit and was able to reproduce the reported issue.The fse determined that the iabp unit will alarm "automatic inflation failed" upon power up, if the unit is turned off for more than 12 hours.Additional information is being requested with regard to the repair and status of the iabp unit.A supplemental report will be submitted when this information is provided to us.(b)(6).Patient height: 170cm.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) alarmed "automatic inflation failure." it was further reported, however, that the end user shut the unit down and when restarting it, the iabp unit did not alarm and operated normally.No patient harm, serious injury or adverse event was reported.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) alarmed "automatic inflation failure." it was further reported, however, that the end user shut the unit down and when restarting it, the iabp unit did not alarm and operated normally.No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
A getinge authorized dealer field service engineer (fse) was dispatched to investigate.The fse evaluated the unit and was able to reproduce the reported issue.The fse determined that the iabp unit will alarm "automatic inflation failed" upon power up, if the unit is turned off for more than 12 hours.The fse performed all safety functional and calibration checks but was unable to determine the cause of the reported issue.The iabp unit passed all testing to factory specifications and was cleared for use and released to the customer.
 
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Brand Name
CARDIOSAVE HYBRID TYPE I PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key11375060
MDR Text Key233462285
Report Number2249723-2021-00382
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108421
UDI-Public10607567108421
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,distri
Type of Report Initial,Followup,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-0800-45
Device Catalogue Number0998-00-0800-45
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MEGA8FR 50CC
Patient Age75 YR
Patient Weight63
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