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

Catalog Number 0998-00-3023-53

Device Problem Suction Problem (2170)

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

Event Date 04/12/2018

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 the company standard operating procedure since the device manufacture date is greater than one year from the event date.At this time getinge service has not been requested to evaluate the iabp.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 ¿low vacuum¿ and was replaced with another iabp.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

A phone call attempt was made, and the biomed (name was not provided) reported that a preventive maintenance was done on (b)(4) 2018, and no failure was found.Preventive maintenance was completed and the iabp was cleared for clinical use.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) alarmed ¿low vacuum¿ and was replaced with another iabp.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

A phone call attempt was made to the customer, and the facility's biomedical engineer reported that a preventive maintenance was done on (b)(6)2018, and no failure was found.Preventive maintenance was completed and the iabp was cleared for clinical use.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) alarmed ¿low vacuum¿ and was replaced with another iabp.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
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 7490091
• MDR Text Key: 107715820
• Report Number: 2249723-2018-00758
• 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,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• 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: 11/05/2018
• Date Device Manufactured: 05/01/2006
• 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: 64 YR
• Patient Weight: 110