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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP CS100; INTRA-AORTIC BALLOON PUMP
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DATASCOPE CORP CS100; INTRA-AORTIC BALLOON PUMP Back to Search Results
Model Number CS100
Device Problem Device Emits Odor (1425)
Patient Problem No Patient Involvement (2645)
Event Date 11/01/2013
Event Type  malfunction  
Event Description
The customer reported that during a routine check of the iabp, the iabp emitted a foul odor.No pt was involved.
 
Manufacturer Narrative
The device history record (dhr) for the iabp involved in the event was reviewed.There were no non-conformances in the dhr related to the reported event.The comp rep evaluated the unit and observed that the battery was deformed and leaking.The comp rep replaced by battery (part #: 0146-00-0039).The iabp was tested to factory specifications.It functioned normally and was released to the customer.The batteries were received by the manufacturing facility at (b)(4) and are on eval.A supplemental medwatch report will be submitted when add'l info becomes available.(b)(4).
 
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Brand Name
CS100
Type of Device
INTRA-AORTIC BALLOON PUMP
Manufacturer (Section D)
DATASCOPE CORP
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
tina evancho, mgr
mahwah, NJ 
9737097265
MDR Report Key3950659
MDR Text Key4640956
Report Number2249723-2014-00793
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 11/01/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCS100
Device Catalogue Number0998-00-3013-XX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/01/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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