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

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.The customer has requested getinge service; however, the iabp is currently in use on a patient.The customer will inform the getinge service territory manager when the pump becomes available.A supplemental report will be submitted.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) will not function properly.It is unclear what the alleged malfunction is and under which circumstances this event occurred; however, there was no patient involvement and no adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit and was unable to reproduce the reported failure.The fse completed calibration, functional testing and safety checks to meet factory specifications.The iabp was returned to customer and cleared for clinical use.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) will not function properly.It is unclear what the alleged malfunction is and under which circumstances this event occurred; however, there was no patient involvement and no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• 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: 7834263
• MDR Text Key: 119027701
• Report Number: 2249723-2018-01500
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2018

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: 08/09/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 10/03/2018
• Supplement Dates FDA Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2017
• 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