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

Catalog Number 0998-00-3023-53

Device Problems Device Displays Incorrect Message (2591); Device Sensing Problem (2917); Data Problem (3196)

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

Event Date 06/24/2018

Event Type  malfunction  

Manufacturer Narrative

Full name of event site: (b)(6). (b)(4). The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date. As of the date of this report getinge service has not been requested. Additional information has been requested, and we will report accordingly if it becomes available.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) alarmed "ap optical sensing module failure" and at times no patient data was available. No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

A follow-up phone call was made to the customer to gather information regarding the status of the iabp unit. The customer reported that a preventative maintenance was performed on the iabp and no parts were replaced. The iabp unit was cleared and returned to clinical use.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) alarmed "ap optical sensing module failure" and at times no patient data was available. The customer called getinge for technical support. The getinge company representative walked the customer through the messages and the iabp was swapped for another. No patient harm, serious injury or adverse event was reported.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 7690968
• Report Number: 2249723-2018-01195
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Age: 44 YR
• Patient Weight: 105