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

Model Number N/A

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A getinge field service engineer (fse) evaluated the iabp and found the an expired 9v battery was expired and replaced it.Unrelated to the reported issue, the executive processor pcb was removed, the fiber optic connector was damaged, the p-clip that secures the coiled cable was broken, and the ion batteries were expired.The fse replaced them all.Full calibration was performed and the unit passed all functional and safety tests per factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had a critical alarm for an expired 9v battery.This was discovered during a previously scheduled repair.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had a critical alarm for an expired 9v battery.This was discovered during a previously scheduled repair.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had a critical alarm for an expired 9v battery.This was discovered during a previously scheduled repair.There was no patient involvement, and no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID DOMESTIC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11077487
• MDR Text Key: 225340696
• Report Number: 2249723-2020-02240
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• 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: 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1