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

Model Number N/A

Device Problem Charging Problem (2892)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit is not required to be reviewed per sop 01-061 since the device manufacture date is greater than one year from the event date.The getinge fse evaluated the iabp and opted to replace the power management board to correct the failure.Full calibration, functional and safety tests were performed and passed to factory specifications.The iabp was cleared for use.

Event Description

It was reported that the batteries of the cardiosave intra-aortic balloon pump (iabp) did not charge correctly during a functional test performed by a getinge field service engineer (fse).There was no patient involvement and no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID
• 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: 8200323
• MDR Text Key: 131942104
• Report Number: 2249723-2018-02223
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• 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: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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