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

Model Number BO-TOP-19100

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2014

Event Type  malfunction  

Event Description

The customer reported that a kit was rec'd where the "sterile integrity is in question".No patient was involved in this incident.

Manufacturer Narrative

The device was returned and an investigation is being performed.A supplemental report will be submitted with the results when the investigation is completed.(b)(4).

• Brand Name: ADULT CPB 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: 3994350
• MDR Text Key: 4777837
• Report Number: 2248146-2014-00225
• Device Sequence Number: 1
• Product Code: DWF
• 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: Other
• Type of Report: Initial
• Report Date: 06/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BO-TOP-19100
• Device Catalogue Number: 701052579
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2014
• Initial Date Manufacturer Received: 06/23/2014
• Initial Date FDA Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: No
• 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