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

Model Number N/A

Device Problems Device Alarm System (1012); Output Problem (3005); Audible Prompt/Feedback Problem (4020)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2018

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.Getinge service was not requested in connection with this event.A supplemental report will be submitted if additional information is made available.

Event Description

It was reported by a getinge company representative that the cardiosave intra-aortic balloon pump (iabp), powered on in service mode and had an accompanying loud continuous audible alarm that sounded like a high pitch whistle.There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

After reviewing emdr follow up#2, it was noticed that the defective part that was mentioned to be returned to nrc for failure investigation as the front end board was not correct.The correct part that was returned to nrc for failure investigation, and then sent to the supplier was the power management board.The nrc received the power management board from the supplier.The supplier could not verify the reported failure; however, they replaced defective u16 that failed during the battery test.The board passed all of their testing and they performed (b)(4).The nrc investigated the suspected power management board and then installed the power management board into cardiosave test fixture and it tested to factory specifications per cardiosave service manual and it passed testing.The board was put into stock/inventory per procedure.

Event Description

It was reported by a getinge company representative that the cardiosave intra-aortic balloon pump (iabp), powered on in service mode and had an accompanying loud continuous audible alarm that sounded like a high pitch whistle.There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

Updated fields: b4,g4,g7,h2,h10.The failed part was returned to the national repair center (nrc).The senior repair technician installed the returned front end board into the cardiosave test fixture and tested to factory specification.The board passed testing and could not verify the reported failure of the battery charging led on the hospital cart was not illumination or charging batteries.The failed part will be sent to the supplier for further evaluation.

Event Description

It was reported by a getinge company representative that the cardiosave intra-aortic balloon pump (iabp), powered on in service mode and had an accompanying loud continuous audible alarm that sounded like a high pitch whistle.There was no patient involvement and no adverse event was reported.

Event Description

It was reported by a getinge company representative that the cardiosave intra-aortic balloon pump (iabp), powered on in service mode and had an accompanying loud continuous audible alarm that sounded like a high pitch whistle.There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

A getinge service territory manager (stm) evaluated the iabp and was able to confirm the reported issue.To address it, the stm replaced the executive processor board, front end board and power management board.The stm additionally replaced the helium assembly due to inability to calibrate the helium fill regulator.The stm also replaced a damaged storage bin chassis and a damage doppler and a missing iv pole.The stm performed a full pm after repair as well as all functional and safety tests which passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.

Event Description

It was reported by a getinge company representative that the cardiosave intra-aortic balloon pump (iabp), powered on in service mode and had an accompanying loud continuous audible alarm that sounded like a high pitch whistle.There was no patient involvement and no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 8192081
• MDR Text Key: 131332428
• Report Number: 2249723-2018-02216
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/15/2020

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: 12/02/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 08/08/2019; 09/23/2019; 10/29/2019; 01/15/2020
• Supplement Dates FDA Received: 08/30/2019; 10/16/2019; 11/18/2019; 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1