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

Model Number N/A

Device Problems Failure to Calibrate (2440); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

Event Type  malfunction  

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 fse replaced the scroll compressor and the batteries.The fse then verified that the iabp was calibrated and passed all functional and safety tests per factory specifications.The iabp was returned to customer and cleared for clinical use.(b)(6).

Event Description

A getinge field service engineer (fse) reported that during routine preventative maintenance (pm) on the cardiosave intra-aortic balloon pump (iabp) he was not able to calibrate the regulator to specification due to a defective scroll compressor.The fse also found that both batteries failed the runtime test.There was 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: 7503810
• MDR Text Key: 108387034
• Report Number: 2249723-2018-00805
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2018

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 Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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