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

Model Number N/A

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to evaluate the iabp unit.The stm found the console was not completely seated in the cart.The stm reseated the console in the cart and all led lights illuminated, and battery leds were blinking.The stm completed all safety, functionality, and calibration checks, and all tests passed to factory specifications.The iabp released to the customer but has not been cleared for clinical use due to it being over due for preventative maintenance (pm).Pm has been scheduled.

Event Description

It was reported that before use with a patient, the cardiosave intra-aortic balloon pump (iabp) had a power switch failure.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) completed a pm with full calibration.The iabp passed all functional and safety tests per factory specifications.Returned to customer and was cleared for clinical use.

Event Description

It was reported that before use with a patient, the cardiosave intra-aortic balloon pump (iabp) had a power switch failure.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: 10561329
• MDR Text Key: 207764780
• Report Number: 2249723-2020-01526
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• 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: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1