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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

The getinge field service engineer (fse) that encountered the issue during pm, found solenoid control board loose.Unable to fully seat solenoid control bd in backplane bd.The fse replaced backplane bd and this corrected the problem.Subsequently, the pm was completed.Device passed all functional and safety tests according to factory specifications.The iabp was returned to customer and cleared for clinical use.(b)(6).

Event Description

It was reported by a getinge field service engineer (fse), during preventive maintenance (pm).The cardiosave intra-aortic balloon pump (iabp) generated an error code 118 (system failure alarm on power up).There was no patient involvement, and no adverse event reported.

Event Description

It was reported by a getinge field service engineer (fse), during preventive maintenance (pm).The cardiosave intra-aortic balloon pump (iabp) generated an error code 118 (system failure alarm on power up).There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

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

• 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: 11350813
• MDR Text Key: 233259091
• Report Number: 2249723-2021-00337
• 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: 04/29/2021

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: 01/27/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1