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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE POWER SUPPLY 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 04/21/2020
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. The getinge service territory manager (stm) reported that the portable power supply has a loose power receptacle, one of the long studs/screw that holds on the retaining clip, broke off and fell out. The stm ordered a new portable power supply for replacement and having it shipped directly to customer. No measurement details available, portable power supply is separate from the iabp. The unit was not made available. This was noticed during an inspection of the iabp and accessories.
 
Event Description
It was reported by the customer that during an inspection of the carrdiosave intra-aortic balloon pump (iabp) and accessories, it was discovered that the portable power supply was damaged. There was no patient involvement, and no adverse event reported.
 
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Brand NameCARDIOSAVE POWER SUPPLY
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 Key10055744
MDR Text Key193376587
Report Number2249723-2020-00750
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 05/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0014-0085
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2016
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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