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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/29/2017
Event Type  malfunction  
Manufacturer Narrative
The field service engineer (fse) replaced the affected cables. The intra-aortic balloon pump (iabp) then passed all functional and safety tests per factory specifications. The iabp was returned to customer and cleared for clinical use.
 
Event Description
The customer reported that there was "no ecg reading" coming from the cs300 intra-aortic balloon pump (iabp) to the remote monitor. The event occurred prior to patient use, thus no injury, harm or adverse event reported.
 
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date. A supplemental report will be submitted upon receiving additional information.
 
Event Description
The customer reported that there was "no ecg reading" coming from the intra-aortic balloon pump (iabp) to the remote monitor. The event occurred prior to patient use, thus no injury, harm or adverse event reported.
 
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Brand NameCS300
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 Key6886286
MDR Text Key104049877
Report Number2249723-2017-00515
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
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 12/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received09/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2007
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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