MAUDE Adverse Event Report: DATASCOPE MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Patient Involvement (2645)

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided by the customer.The customer has not requested getinge to evaluate the iabp.However, the customer has purchased another supply and will handle the repairs internally.Additional information has been requested, and if made available, a supplemental report will be submitted.

Event Description

It was reported that during a preventative maintenance (pm) by the customer, an unknown intra-aortic balloon pump (iabp) failed the power supply check.No patient was involved during this event.No adverse event was reported.

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.The customer has advised that the power supply was replaced and this resolved the issue.Per the customer, the iabp has been returned to clinical service.(b)(4).

Event Description

It was reported that during a preventative maintenance (pm) by the customer, the cs100 intra-aortic balloon pump (iabp) failed the power supply check.No patient was involved during this event.No adverse event was reported.

• Brand Name: CS100
• 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: 7542080
• MDR Text Key: 109491882
• Report Number: 2249723-2018-00886
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0998-00-3013-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 06/12/2018
• Date Device Manufactured: 05/01/2004
• 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