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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION UNKNOWN IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SENSATION UNKNOWN IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number UNKNOWN
Device Problems Break (1069); Device Sensing Problem (2917)
Patient Problem Death (1802)
Event Date 05/03/2018
Event Type  Death  
Manufacturer Narrative
The device was not returned and could not be evaluated. It was discarded by the user. We are unable to confirm the reported event. If new information becomes available, a supplemental report will be submitted. (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy with a fiber optic catheter that the patient went into full code with loss of the optical sensor and electrocardiogram (ecg) signal. An optical sensor failure alarm was generated. There could have been a possible fiber optic break in the catheter due to cpr(cardiopulmonary resuscitation). There was an attempt to establish blood pressure signal via central lumen, but the customer was having trouble finding the cable. An ecg signal was present, but poor. The emergency service specialist informed the customer to switch to a semi-auto mode and attempt to find a lead that could be seen. There was a weak signal established in avr(augmented vector right) but not strong enough for pump to pick-up r waves. Finally the customer was able to get the cable and hooked up to the transducer. The patient proceeded to code again. After zeroing, the customer was able to get a pressure signal from cpr effort and pump began working. The emergency service specialist verified that the customer had cables on each pump for pressure transducer. The patient expired due to underlying disease, but the death was not attributed to the device by the facility. The date of death is unknown.
 
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Brand NameSENSATION UNKNOWN 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 Key7554415
MDR Text Key109615635
Report Number2248146-2018-00364
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/30/2018 Patient Sequence Number: 1
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