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

Catalog Number 0998-00-3023-53

Device Problems Failure to Power Up (1476); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) confirmed the iabp had no ac power.The stm checked all fuses, the power cord, and switches.All of them were ok.The stm replaced the power supply and the problem resolved.The iabp passed at safety testing and was cleared for clinical use.The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) has no ac power, and the iabp is always running on battery.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: 7135196
• MDR Text Key: 95734810
• Report Number: 2249723-2017-01038
• 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
• Report Date: 12/18/2017

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 Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2016
• 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