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

Model Number N/A

Device Problems Failure to Calibrate (2440); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.Getinge service was not required for this complaint event.However, a getinge service territory manager (stm) spoke with the in-house technician at the event site and explained to him that event log fault code 77 is a normal occurence that results when the compressor makes adjustments to speed, and per the service manual this code with the description of ¿compressor motor adjustment¿, is a minor fault which states ¿no action required¿.The clinical engineering department was asked what was the reason for examining the fault logs and they stated that the end user reported the balloon was not calibrating.Subsequently they determined that the ¿calibration error¿ was a user error which was discussed/corrected during the in-service.No further investigation is required.

Event Description

It was reported that during in-service training, the intra-aortic balloon (iab) was not calibrating.After the customer examined the fault logs of the cardiosave intra-aortic balloon pump (iabp), fault # 77 was observed twice.There was no patient involvement and no adverse event was reported.

• Brand Name: CARDIOSAVE
• 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: 7582725
• MDR Text Key: 110864092
• Report Number: 2249723-2018-00969
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2018
• Date Device Manufactured: 04/11/2018
• 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