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

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2018

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 was not requested to service the iabp.However, a new removable power supply was shipped to the customer as goodwill.The full name of the event site noted is (b)(6) medical center (tp).

Event Description

The customer reported that the cardiosave intra-aortic balloon pump (iabp) rescue power supply was not functional, and that the power supply cord was replaced last year, but was barely used and was sitting on a shelf.The circumstance under which the event occurred is unknown; however, there was no patient involvement, and no adverse event was reported.

Manufacturer Narrative

The transport power supply was replaced by biomed and the iabp was cleared for clinical use.

Event Description

The customer reported that the cardiosave intra-aortic balloon pump (iabp) rescue power supply was not functional, and that the power supply cord was replaced last year, but was barely used and was sitting on a shelf.The circumstance under which the event occurred is unknown; however, there was no patient involvement, and no adverse event was reported.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 7519460
• MDR Text Key: 108802056
• Report Number: 2249723-2018-00839
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• 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: 0998-00-0800-83
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 10/10/2018
• Date Device Manufactured: 02/01/2016
• 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