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

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date.Additional information has been requested.A supplemental report will be sent upon receiving this information.The full name of the event site is (b)(6).

Event Description

It was reported that during inspection by a getinge field service engineer (fse) service in getinge japan office, the touch panel of the cardiosave intra-aortic balloon pump (iabp) did not respond.There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

To address the issue, the getinge field service engineer (fse) opted to replace the touchscreen assembly.The fse confirmed the improvement of symptoms after the repair was completed.Inspection was performed and the iabp operated to specifications.The iabp unit was then cleared for clinical use.

Event Description

It was reported that during inspection by a getinge field service engineer (fse) service in getinge (b)(4) office, the touch panel of the cardiosave intra-aortic balloon pump (iabp) did not respond.There was no patient involvement and no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 8442237
• MDR Text Key: 139718655
• Report Number: 2249723-2019-00443
• Device Sequence Number: 1
• Product Code: DSP
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• 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
• Device Age: YR
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1