MAUDE Adverse Event Report: DATASCOPE CORP. ADULT ECC PACK; CARDIOPULMONARY DEVICE

Model Number BO-TOP 16402

Device Problem Component Missing (2306)

Patient Problem Surgical procedure, repeated (2042)

Event Date 04/18/2014

Event Type  malfunction  

Event Description

It was reported that the end of the pressure tubing was missing a connector.It appeared that the connector may have separated from the tubing.No adverse events were reported.

Manufacturer Narrative

The device was not returned for evaluation, therefore an evaluation could not be performed to determine root cause.The customer was able to use the kits without incident.Device history records were reviewed and no non-conformities were found related to this failure mode.Complaint history was reviewed and no similar complaints were found.If the device is returned or additional information is received, a supplemental report will be submitted.(b)(4).

• Brand Name: ADULT ECC PACK
• 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: 4013974
• MDR Text Key: 16850397
• Report Number: 2248146-2014-00077
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2015
• Device Model Number: BO-TOP 16402
• Device Catalogue Number: 701054787
• Device Lot Number: 16259-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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