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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Device Inoperable (1663); Charging Problem (2892)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/17/2017
Event Type  malfunction  
Manufacturer Narrative
A third party supplier evaluated the iabp and replaced the batteries. In addition, the safety disc and scroll compressor were also replaced. It was reported that the iabp was tested, and passed all functional and safety test per factory specifications. The iabp was then released to the customer and cleared for clinical service.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) could not operate on battery. It was also reported that when it was connected to the main power supply the batteries were charging but no more than one led. There was nothing wrong seen in diagnostic mode. The batteries are about 4 years old. There was no adverse event reported.
 
Manufacturer Narrative
An authorized getinge distributor evaluated the iabp and replaced the batteries. In addition, unrelated to the reported failure the safety disk and scroll compressor were also replaced as part of warranty. Furthermore, it was reported that the iabp was tested, and passed all functional and safety checks per factory specifications. The iabp was then released to the customer and cleared for clinical service. The event site's full name and address were abbreviated as the hospital name and address exceeded maximum character limit. (previously reported the operator of the device was reported to be unknown, but in fact the "operator of device" was reported to be an authorized getinge distributor).
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) could not operate on battery. It was also reported that when the iabp was connected to the main power supply the batteries were charging, but no more than one led. When the iabp was in diagnostic mode, there were no abnormalities present. The batteries were reported to be about 4 years old. There was no patient involvement or adverse event reported.
 
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) could not operate on battery. It was also reported that when the iabp was connected to the main power supply the batteries were charging, but no more than one led. When the iabp was in diagnostic mode, there were no abnormalities present. The batteries were reported to be about 4 years old. There was no patient involvement or adverse event reported.
 
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not reviewed per company standard operating procedure since the device serial number was not provided. Additional information has been requested and will be provided if received.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) could not operate on battery. It was also reported that when it was connected to the main power supply the batteries were charging but no more than one led. There was nothing wrong seen in diagnostic mode. The batteries are about 4 years old. There was no adverse event reported.
 
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Brand NameCARDIOSAVE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key7186877
MDR Text Key108260695
Report Number2249723-2018-00057
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeBU
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2018
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-XX
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received06/04/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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