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

Model Number N/A

Device Problem Output below Specifications (3004)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2019

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.The customer replaced solenoid driver board.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that during preventive maintenance (pm) performed by the customer, the cs300 intra-aortic balloon pump iabp failed to meet factory specifications on the solenoid driver board checks, and the voltage was reading low.There was no patient involvement; thus no adverse event was reported.

Event Description

It was reported that during preventive maintenance (pm) performed by the customer, the cs300 intra-aortic balloon pump iabp failed to meet factory specifications on the solenoid driver board checks, and the voltage was reading low.There was no patient involvement; thus no adverse event was reported.

Manufacturer Narrative

Three (3) good faith efforts (gfes) to obtain the relevant repair and iabp status related to this complaint issue were made to the customer.However, despite our best efforts, customer has not responded to any of our gfes.If additional information is provided, we will submit a supplemental report.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 8975886
• MDR Text Key: 187570735
• Report Number: 2249723-2019-01439
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• 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: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1