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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 Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 06/24/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge service territory manager (stm) was dispatched to evaluate the iabp and was able to confirm the reported issue. The stm was able to verify that the iabp was charging in both slots by placing known good batteries in each and discovered that the defective battery would not charge in either slot. To address the issue the stm replaced the battery and performed all functional and safety tests which passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service. (b)(6).
 
Event Description
It was reported that the batteries will not charge when the cardiosave intra-aortic balloon pump (iabp) is plugged into ac. When plugged into ac the ac green light comes on but the battery charging light does not come on and the batteries are not being charged. It is unknown under which circumstances this event occurred; however there was no patient involvement and no adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10290092
MDR Text Key199312859
Report Number2249723-2020-01103
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 07/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2019
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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