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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 0684-00-0568-01
Device Problems Moisture Damage (1405); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 06/12/2017
Event Type  malfunction  
Manufacturer Narrative
A visual inspection confirmed the presence of fluid inside the packaging of the returned device. It was suspected that the fluid was silicone. Devices were sampled and sent for infra-red spectrophotometer (ir) testing. The results confirmed that the substance was silicone which had migrated inside the packaging of the device during storage. Silicone is used as a lubricant during the manufacturing process and has been determined to be biocompatible. Devices with silicone found in the packaging can continue to be used and pose no risk to the patient. The event has been confirmed, there was no malfunction of the reported devices. (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 (b)(4). There was no patient involvement. This mdr is for #35 of 50 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 Key6942209
MDR Text Key90292712
Report Number2248146-2017-00503
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 distributor
Reporter Occupation
Type of Report Initial
Report Date 10/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2020
Device Catalogue Number0684-00-0568-01
Device Lot Number3000050881
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received09/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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