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

Catalog Number 0998-00-0800-53

Device Problem Failure to Calibrate (2440)

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

Event Type  malfunction  

Event Description

During preventive maintenance (pm) by the company service representative it was found that the pressure regulator would not calibrate. No patient involvement or adverse event reported.

Manufacturer Narrative

09/14/2017 02:08 pm (gmt-4:00) added by (b)(6) (pid-(b)(4)): on 24 aug 2017 the service territory manager confirmed that the correct aware date of the parent record is 12 june 2017. Corrected: (parent) aware date.

Event Description

During preventive maintenance (pm) by the company service representative it was found that the pressure regulator would not calibrate. No patient involvement or adverse event reported.

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 company service representative disassembled the iabp, replaced the drive pressure regulator and completed all the functional checkout procedures. The iabp was cleared for clinical use and returned to the customer.

Event Description

During preventive maintenance (pm) by the company service representative it was found that the pressure regulator would not calibrate. No patient involvement or adverse event reported.

• Brand Name: CARDIOSAVE
• 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: 6708358
• MDR Text Key: 104045737
• Report Number: 2249723-2017-00085
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse