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

Model Number N/A

Device Problems Display or Visual Feedback Problem (1184); No Audible Prompt/Feedback (2282); Defective Device (2588); Battery Problem (2885)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/02/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.The fse that discovered the issue has advised that the alarm daughter board has been ordered and will be replaced in the iabp.A supplemental report will be submitted when additional information is made available.The full event site address in the 1st address field is (b)(6).

Event Description

It was reported that during preventative maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) would not generate a beep sound after pushing the test button on the alarm daughter board.It was noted that the 9v battery was replaced and still no alarm was heard.The fse suspected that the alarm daughter board was defective.There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

Upon further evaluation by the getinge field service engineer (fse) it was found that the battery which was taken from the doppler to troubleshoot the issue does not work with the alarm daughter board.The fse installed a new 9v battery (as part of the preventative maintenance protocol) and the alarm daughter board worked with beep sound when the test button was pushed.The fse completed all safety, functionality, and calibration checks and all tests passed per factory specifications.The iabp unit was returned to the customer and cleared for clinical use.

Event Description

It was reported that during preventative maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) would not generate a beep sound after pushing the test button on the alarm daughter board.It was noted that the 9v battery was replaced and still no alarm was heard.The fse suspected that the alarm daughter board was defective.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 MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 8272609
• MDR Text Key: 134081926
• Report Number: 2249723-2019-00120
• 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: 05/16/2019

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: 0998-00-0800-52
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 01/23/2019
• Supplement Dates Manufacturer Received: 04/18/2019
• Supplement Dates FDA Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1