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

Model Number N/A

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The getinge field service engineer (fse) that encountered the issue replaced the pneumatic module assembly and performed 30 psi calibration procedure.The fse found the fiber optic connector was damaged and replaced the front end assembly.Pm was completed during the same service visit.Full calibration, functional, and safety checks were performed which passed to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse), the x1 transducer of the cardiosave intra-aortic balloon pump (iabp) would not calibrate.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse), the 30 psi calibration could not be completed and the x1 transducer of the cardiosave intra-aortic balloon pump (iabp) would not calibrate.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Corrected fields: b5, d1, e1 (event site name, event site address, event site postal code, event site telephone).

• 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: 11096412
• MDR Text Key: 224598683
• Report Number: 2249723-2020-02247
• 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
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1