MAUDE Adverse Event Report: DATASCOPE CORP. ECC 1/4" SET; CARDIOPULMONARY DEVICE

Model Number BEQ-TOP 33704

Device Problem Malfunction (2409)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2013

Event Type  malfunction  

Event Description

Patient noticed air entering the system at the connector entering the better bladder (small amount) and felt it was due to the tyband connector being to close to the edge of the connector.They resolved the issue by applying another tyband further onto the connector.The territory manager was told there was no patient effects as all of the air was entrapped in the better bladder and the bubble sensor never alarmed during this situation.The territory manager also tried to determine why this was not noticed during priming and if the negative pressure was abnormally high.

Manufacturer Narrative

The product was not returned for evaluation.A review of the device history does not indicate any lot specific issues.(b)(4).

• Brand Name: ECC 1/4" SET
• Type of Device: CARDIOPULMONARY DEVICE
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ
• Manufacturer Contact: jason de sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 3979573
• MDR Text Key: 4888353
• Report Number: 2248146-2014-00296
• Device Sequence Number: 1
• Product Code: DWE
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: BEQ-TOP 33704
• Device Catalogue Number: 701054150
• Device Lot Number: 14997-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1