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

Model Number N/A

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date. (b)(6). A getinge service territory manager (stm) was dispatched to evaluate the intra-aortic balloon pump (iabp). The stm was able to confirm the reported issue. The problem was due to a faulty power supply. The stm disassembled the unit, removed and replaced the power supply. The stm completed all safety, functionality, and calibration checks and all tests passed to factory specifications. The iabp is due for preventative maintenance (pm) at which time the batteries and safety disk will be replaced and the unit returned to clinical use.

Event Description

It was reported the cs300 intra-aortic balloon pump (iabp) would not start and had error code 7. It is unknown under which circumstances this event occurred; however there was no patient involvement, thus no adverse event was reported.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 9671466
• MDR Text Key: 191839235
• Report Number: 2249723-2020-00175
• 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

• Type of Report: Initial,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3053-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse