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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0567
Device Problems Moisture Damage (1405); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 07/21/2017
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. We continue our efforts to follow up for its return. (b)(4).
 
Event Description
It was reported that 50 devices of this batch have fluid visible between the tray and tray cover with no sign of fluid contamination from the outside. The packaging is reported to be intact. This was reported by a distributor in south africa. This product was not shipped to the end user and therefore there was no patient involvement. This mdr is for 45 of 50 of the devices.
 
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Brand NameSENSATION PLUS 7.5FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key6786178
MDR Text Key82615174
Report Number2248146-2017-00291
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSA
PMA/PMN Number
K122628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 08/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/21/2020
Device Catalogue Number0684-00-0567
Device Lot Number3000047641
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received07/21/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/21/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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