MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0998-00-3023-53

Device Problems Failure to Charge (1085); Low Battery (2584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2017

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.Customer has not requested service from getinge.  we have requested additional information from the customer, and we will report accordingly if the information is provided to us.

Event Description

The customer reported that while attempting transport a patient, the battery died and would not charge.There was no patient injury or adverse event reported.

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformance's related to the reported event were noted.This iabp is serviced by a third party company.This complaint is being closed due to insufficient information from the service company after various good faith efforts were made to obtain the relevant information.If additional information is provided in the future, in regards to this event, a supplemental report will be sent.The correct serial number should have been documented as "(b)(4)".

Event Description

The customer reported that while attempting transport a patient, the battery died and would not charge.There was no patient injury or adverse event reported.

• Brand Name: CS300
• 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: 6788976
• MDR Text Key: 82770039
• Report Number: 2249723-2017-00269
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 10/20/2017
• Date Device Manufactured: 09/16/2003
• 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
• Patient Age: 72 YR