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

Model Number N/A

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 12/19/2019

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 company standard operating procedure since the device manufacture date is greater than one year from the event date.The getinge field service engineer (fse) order the power supply board and will replace once received.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that during a service visit by a getinge field service engineer (fse), it was observed that there was no power output on the power supply board.Since the event occurred during a service visit, there was no patient involved and no adverse event was reported.

Event Description

It was reported that during a service visit by a getinge field service engineer (fse), it was observed that there was no power output on the power supply board.Since the event occurred during a service visit, there was no patient involved and no adverse event was reported.

Manufacturer Narrative

The initial reporter named in block e1 is a getinge employee who has different contact details from that of the event site, and has the following contact information: (b)(6).The getinge field service engineer (fse) that ordered the power supply board reported that he tried to replace the power management board and power supply monitor board, but without success.The fse finally noticed that, previously replacing the compressor, he had pulled the whole pack of cables and, almost unplugged the vcc connector on the backplane.It remained ¿almost¿ in place and finally got disconnected when the fse moved the iabp unit to replace the mains cable reel.Once plugged back, the iabp unit worked correctly.The power supply board, power management board and power supply monitor board were finally not involved.The only defects on this iabp unit were the compressor and the mains cable reel that were replaced.The fse mentioned to the biomed to let the iabp unit go to full charge until the next day.They would then check the charge and power on with and without the mains to check the ps functions then back to use.All functional and safety checks to meet factory specifications were performed.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

• Brand Name: CARDIOSAVE HYBRID INT TYPE E/F 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: 9682882
• MDR Text Key: 191751007
• Report Number: 2249723-2020-00191
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• 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: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1