MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE; 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 05/30/2018

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 when additional information is made available.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had an electrical safety test failure.It is unknown under which circumstances this event occurred or if a patient was involved.However, no adverse event was reported.

Manufacturer Narrative

Please note, the date of the initial emdr should have been reported as (b)(6) 2018.The initial reporter named is a getinge employee whose contact information is: email address (b)(6); which differs from that of the event site.A getinge fse evaluated the iabp unit and replaced the power cord reel.The iabp unit passed the power cord resistance to specifications.The pm was completed and the iabp passed all functional and safety tests to factory specifications.The unit was returned to the customer and cleared for clinical use.

Event Description

While performing a preventative maintenance (pm), the getinge field service engineer (fse) discovered that the cardiosave intra-aortic balloon pump (iabp) failed the electrical safety test with a resistance above specifications.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: 7627154
• MDR Text Key: 112453722
• Report Number: 2249723-2018-01050
• 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
• Report Date: 07/25/2018

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: Other
• Device Model Number: N/A
• 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
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 06/29/2018
• Supplement Dates FDA Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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