MAUDE Adverse Event Report: DATASCOPE SENSATION 7FR. 40CC IAB; INTRA-AORTIC BALLOON

Model Number 0684-00-0434

Device Problem Alarm, audible (1010)

Patient Problem Death (1802)

Event Type  Death  

Event Description

An optical sensor failure was reported for a pt with an iab.The iab is still being used with a alternative arterial pressure source.

Manufacturer Narrative

The product was not returned for evaluation.We will continue to monitor for this issue.Internal file number: (b)(4).

• Brand Name: SENSATION 7FR. 40CC IAB
• Type of Device: INTRA-AORTIC BALLOON
• Manufacturer (Section D): DATASCOPE; fairfield NJ
• Manufacturer Contact: jason de sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 3885487
• MDR Text Key: 20975436
• Report Number: 2248146-2014-00103
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2014
• Device Model Number: 0684-00-0434
• Device Catalogue Number: 0684-00-0470-01
• Device Lot Number: 2644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2011
• Initial Date FDA Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death