MAUDE Adverse Event Report: DATASCOPE MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.

Event Description

During in-service training the customer reported that the auto button on the cs100 intra-aortic balloon pump (iabp) did not work.There was no patient involvement or adverse event reported.

Manufacturer Narrative

A company representative made various attempts to retrieve additional information in regards to repair information.Unfortunately, there was no further information provided.If any details of this event is provided a supplemental report will be provided.

Event Description

During in-service training the customer reported that the auto button on the cs100 intra-aortic balloon pump (iabp) did not work.There was no patient involvement or adverse event reported.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 7042615
• MDR Text Key: 93073408
• Report Number: 2249723-2017-00819
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3013-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Date Device Manufactured: 02/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1