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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP., SENSATION 7FR 40CC IAB; INTRA-AORTIC BALLOON CATHETER
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DATASCOPE CORP., SENSATION 7FR 40CC IAB; INTRA-AORTIC BALLOON CATHETER Back to Search Results
Model Number 0684-00-0434
Device Problem Alarm, audible (1010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/02/2014
Event Type  Injury  
Event Description
The customer stated that the pump hasn't pumped for 30 minutes while in use on a patient who was having violent seizures post cardiac arrest, is intubated and on vasopressors.The pump continuously alarmed "check iab catheter" and "iab optical sensor failure" despite troubleshooting.The physician was contacted to discontinue therapy.The patient was reported to be in stable condition after the event.
 
Manufacturer Narrative
The device has not been returned for evaluation.If the product is received or additional information obtained, a supplemental report will be submitted.(b)(4).
 
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Brand Name
SENSATION 7FR 40CC IAB
Type of Device
INTRA-AORTIC BALLOON CATHETER
Manufacturer (Section D)
DATASCOPE CORP.,
fairfield NJ
Manufacturer Contact
jason sousa
15 law dr.
fairfield, NJ 07004
9737097256
MDR Report Key3875987
MDR Text Key4511566
Report Number2248146-2014-00084
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 Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/18/2016
Device Model Number0684-00-0434
Device Catalogue Number0684-00-0470-01
Device Lot Number2957
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/03/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age81 YR
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