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

Model Number N/A

Device Problem Failure to Charge (1085)

Patient Problem No Patient Involvement (2645)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

The getinge service territory manager (stm) that encountered the issue replaced the batteries and completes full preventive maintenance (pm) with full calibration.Functional testing and safety test passed according to factory specifications.The iabp was returned to customer and cleared for clinical use.The initial reporter named in is a getinge employee whose contact details are: (b)(6), which differs from that of the event site.

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm).The battery capacity in the cardiosave intra-aortic balloon pump (iabp) showed prompt of less than 30 minutes in yellow status, and five minutes later showed less than 5 minutes of runtime in red.In addition, the stm informed that battery would not charge after that.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm).The battery capacity in the cardiosave intra-aortic balloon pump (iabp) showed prompt of less than 30 minutes in yellow status, and five minutes later showed less than 5 minutes of runtime in red.In addition, the stm informed that battery would not charge after that.There was no patient involvement, and no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11349166
• MDR Text Key: 232577795
• Report Number: 2249723-2021-00335
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• 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
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1