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

Model Number N/A

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the unit and replaced the entire ac line cord assembly and safely connected it to the bulk ac power supply inside the hospital cart.Thereafter, the fse performed a complete system check out with full calibration, as well as performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that the power cord of the cardiosave intra-aortic balloon pump (iabp) was broken.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event reported.

Event Description

It was reported that during a routine check, the power cord of the cardiosave intra-aortic balloon pump (iabp) was broken.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The getinge field service engineer (fse) noted that the ground pin on the power cord was broken and caused due to customer abuse of the cardiosave intra-aortic balloon pump (iabp) unit.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h4, h6 (type of investigation), h10.

Event Description

It was reported that during a routine check, the power cord of the cardiosave intra-aortic balloon pump (iabp) was broken.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: 11381995
• MDR Text Key: 233749402
• Report Number: 2249723-2021-00432
• 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,Followup
• Report Date: 06/04/2021

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
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/22/2021; 06/04/2021
• Supplement Dates FDA Received: 04/12/2021; 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1