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

Catalog Number 0998-00-3023-53

Device Problem Charging Problem (2892)

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

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Additional information has been requested, however, no further details have been provided.If any additional information is provided in the future, a supplemental report will be provided.

Event Description

A getinge cardiac assist account manager (caam) reported that while he was on site doing intra-aortic balloon pump (iabp) training the cs300 iabp being used for training did not seem to be charging or holding a charge of its on-board battery.This event occurred during in-service training.There was no patient involved and no adverse event reported.

Manufacturer Narrative

A getinge cardiac assist territory manager (catm) reported that they have reached out to the facility to obtain the serial number of the iabp, unfortunately the facility is not sure which pump had the reported battery issue.The catm also stated that the facility's iabps received new batteries on (b)(4).The facility also received new cardiosave iabps on (b)(4) and the old iabps will not be in utilization any longer.

Event Description

A getinge cardiac assist account manager (caam) reported that while he was on site doing intra-aortic balloon pump (iabp) training the cs300 iabp being used for training did not seem to be charging or holding a charge of its on-board battery.This event occurred during in-service training.There was no patient involved and no 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: 7148640
• MDR Text Key: 96014466
• Report Number: 2249723-2017-01070
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: No
• 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