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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 Failure to Power Up (1476); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 05/10/2018
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 authorized distributor who found the issue installed another set of datasettes and the iabp started up.Full event site name: (b)(6).Full name of initial reporter: (b)(6).
 
Event Description
It was reported that during a field action performed by a getinge authorized distributor, the cs100 intra-aortic balloon pump (iabp) failed to power up when the new datasettes were introduced.The distributor attempted to replace with a 2nd set of datasettes and discovered that the part malfunctioned as an out of box (oob) failure.There was no patient involvement and no adverse event was reported.The 1st set of datasettes that failed (oob) was reported under mfg report# 2249723-2018-01619.
 
Manufacturer Narrative
The faulty datasette dss was returned to the getinge national repair center (nrc) for further evaluation of the out of box (oob) failure.A senior repair technician of the nrc inspected the datasette dss and no visual damage was observed.The technician installed the datasette dss into the main board of a cs100 test fixture and tested to factory specifications per cs100 service manual.The part failed testing and the reported failure "pump failed to power up" was verified.The datasette will be sent to the supplier for failure analysis per procedure.
 
Event Description
It was reported that during a field action performed by a getinge authorized distributor, the cs100 intra-aortic balloon pump (iabp) failed to power up when the new datasettes were introduced.The distributor attempted to replace with a 2nd set of datasettes and discovered that the part malfunctioned as an out of box (oob) failure.There was no patient involvement and no adverse event was reported.The 1st set of datasettes that failed (oob) was reported under mfg report# 2249723-2018-01619.
 
Event Description
It was reported that during a field action performed by a getinge authorized distributor, the cs100 intra-aortic balloon pump (iabp) failed to power up when the new datasettes were introduced.The distributor attempted to replace with a 2nd set of datasettes and discovered that the part malfunctioned as an out of box (oob) failure.There was no patient involvement and no adverse event was reported.The 1st set of datasettes that failed (oob) was reported under mfg report# 2249723-2018-01619.
 
Manufacturer Narrative
The datasette dss was returned to the getinge national repair center (nrc) from the supplier.The supplier was able to verify the reported failure.They stated that u1 is un-programmable.The datasette was scrapped and retained in the nrc per procedure.
 
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Brand Name
CS100
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key7940348
MDR Text Key123203882
Report Number2249723-2018-01721
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
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-XX
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Device Age YR
Initial Date Manufacturer Received 05/14/2018
Initial Date FDA Received10/05/2018
Supplement Dates Manufacturer Received10/04/2018
12/11/2018
Supplement Dates FDA Received10/30/2018
01/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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