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

Model Number N/A

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

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.A getinge field service engineer (fse) evaluated the iabp and found that the cable drum (power cord reel) was the cause of the issue and not the power supply.To resolve the issue, the fse replaced the cable drum (power cord reel), and then performed all functional and safety tests which passed to meet factory specifications.The iabp was returned to the customer and cleared for clinical service.Full event site name: (b)(4).

Event Description

It was reported that during daily checks performed by the customer, it was found that the led indicators were not illuminated and there was no power going to the cardiosave intra-aortic balloon pump (iabp).As the customer is getinge serviced trained, they investigated the fault and found that the 15v rail was missing from the power supply module in the hospital cart.Subsequently, a replacement power supply module was ordered with a follow-up to be conducted by a getinge engineer.There was no patient involvement, and no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID INT TYPE G PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 9629800
• MDR Text Key: 191272392
• Report Number: 2249723-2020-00124
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-52
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1