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

Catalog Number 0998-00-0800-53

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

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.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) ecg and pressure monitor ports were loose.It is unknown under which circumstances this event occurred.However, no patient involvement or adverse event was reported.

Manufacturer Narrative

Evaluation conclusion code (b)(4).Cause traced to component failure.A getinge service territory manager (stm) was dispatched to evaluate this unit.The stm found that the ecg and pressure ports were a little loose and had play.Too resolve the issue, the stm took the front cover off and used pliers to tighten the lock nut.The stm then tested the ports and performed functional and safety checks to factory specifications, and the iabp was returned to the customer and cleared for clinical use.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) ecg and pressure monitor ports were loose.It is unknown under which circumstances this event occurred.However, no patient involvement or adverse event was reported.

Manufacturer Narrative

Corrected field:(initial reporter name and email address was previously omitted - the email address is "(b)(6) updated fields:.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) ecg and pressure monitor ports were loose.It is unknown under which circumstances this event occurred.However, no patient involvement or 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: 7597608
• MDR Text Key: 111452123
• Report Number: 2249723-2018-01002
• 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,Followup,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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