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

Model Number N/A

Device Problem Device Inoperable (1663)

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

Event Date 08/29/2017

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.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported that there was "no ecg reading" coming from the intra-aortic balloon pump (iabp) to the remote monitor.The event occurred prior to patient use, thus no injury, harm or adverse event reported.

Manufacturer Narrative

The field service engineer (fse) replaced the affected cables.The intra-aortic balloon pump (iabp) then passed all functional and safety tests per factory specifications.The iabp was returned to customer and cleared for clinical use.

Event Description

The customer reported that there was "no ecg reading" coming from the cs300 intra-aortic balloon pump (iabp) to the remote monitor.The event occurred prior to patient use, thus no injury, harm 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: 6886286
• MDR Text Key: 88168517
• Report Number: 2249723-2017-00515
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• 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: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2007
• 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