MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Date 01/18/2018

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.The field service engineer (fse) completed the field action and safety checks to factory specifications.In addition the fse advised the customer not to return the iabp to clinical service until an investigation was performed.The customer agreed, but did not want any action taken at this time.(b)(6).A supplemental report will be submitted if additional information is provided.

Event Description

It was reported that during the solenoid driver board field action by a getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp) failed the battery run time test.The iabp ran on the back up battery for 255 minutes after a full charge.There was no patient involvement or adverse event reported.

Manufacturer Narrative

The customer reported that it is unknown when the iabp will be repaired or released for clinical use.

Event Description

It was reported that during the solenoid driver board field action by a getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp) failed the battery run time test.The iabp ran on the back up battery for 255 minutes after a full charge.There was no patient involvement or adverse event reported.

• Brand Name: CS300
• 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: 7259898
• MDR Text Key: 99998025
• Report Number: 2249723-2018-00221
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2018
• Date Device Manufactured: 05/01/2001
• 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