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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 Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 07/24/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge service territory manager (stm) was dispatched to evaluate the iabp unit. The stm spoke via telephone with the customer who advised the iabp is not charging the batteries. The customer was asked to verify the iabp was latched in the cart. The customer determined that the iabp was not inserted into the cart and that is why it was not charging. Once the latch to remove the iabp from the cart is pulled the iabp will no longer charge it is reinserted into the cart. This is normal operation of the iabp. Once the iabp was reinserted into the cart the charger came on and the iabp operated normally. The iabp was returned to clinical use.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) will not turn on. The power indicator is on. No patient harm, serious injury or 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 Key10414590
MDR Text Key203155012
Report Number2249723-2020-01285
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2020
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2017
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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