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

Model Number N/A

Device Problems Corroded (1131); Failure to Calibrate (2440)

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

Event Date 08/22/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) unit is not required to be reviewed as per the company standard operating procedure since the device manufacture date is greater than one year from the event date. During a pm service, the getinge field service engineer (fse) evaluated the front-end board and noticed it would not calibrate. To fix the issue, the fse replaced front end board as per manufacturer specifications. The fse completed the pm and the unit passed all functional and safety tests per factory specifications. The iabp was then released to the customer for return to clinical service. The full name of the event site noted (b)(6) hospital.

Event Description

During a preventive maintenance (pm) performed by a getinge field service engineer (fse), the front-end board of the cs300 intra-aortic balloon pump (iabp) could not calibrate. The fse performed a transducer calibration and the front end board was not adjusting. The fse noticed that the front end board has corrosion damage from saline. No patient was involved during this event. No adverse event was 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: 7870105
• MDR Text Key: 120245545
• Report Number: 2249723-2018-01580
• 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

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/12/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/12/2018
• 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?: Yes

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse