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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Device Alarm System (1012); Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit is not required to be reviewed per sop 01-061 since the device manufacture date is greater than one year from the event date. A getinge service territory manager (stm) evaluated this unit and was able to reproduce the reported issue. The stm replaced the keypad assembly and keypad overlay. The unit was returned to the customer and cleared unit for clinical use.
 
Event Description
It was reported that the cs100 intra-aortic balloon pump (iabp) presented a keypad malfunction. It was later reported by the getinge service territory manager (stm) that when the biomed brought the iabp for the completion of a demand preventative maintenance (pm), he was informed that the "aug alarm" button was intermittently not functioning. 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 NameCS100
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 Key7707543
MDR Text Key114846870
Report Number2249723-2018-01227
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 07/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-3013-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2006
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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