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

Model Number N/A

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Production device history record (dhr) review is not required as there was no malfunction of the cardiosave intra-aortic balloon pump; complaint event is due to an out-of-box failure of a getinge-manufactured part.The event site's full name was abbreviated as the name exceeded maximum character limit.The complete name is, "(b)(6)." additional information has been requested.A supplemental report will be sent upon receipt.

Event Description

It was reported that a new cardiosave intra-aortic balloon pump's (iabp) retractable power cord was received with damages.The power cord assembly could not be used due to these damages and has been deemed an out-of-box failure.This component requires replacement.There was no patient involvement or adverse event reported.

Manufacturer Narrative

The failed out of box part was returned to our national repair center for evaluation and inspection of the reel, ac power cord type b plug was completed with visual damage observed.The ac cord reel bracket fab was bent at the pem installed near the ac plug.Based on the visual inspection, the reel, ac power cord type b plug failed testing.

Event Description

It was reported that a new cardiosave intra-aortic balloon pump's (iabp) retractable power cord was received with damages.The power cord assembly could not be used due to these damages and has been deemed an out-of-box failure.This component requires replacement.There was no patient involvement or adverse event reported.

Manufacturer Narrative

The company representative has advised that the power cord was replaced in substitution of the power cord that failed out of box.

Event Description

It was reported that a new cardiosave intra-aortic balloon pump's (iabp) retractable power cord was received with damages.The power cord assembly could not be used due to these damages and has been deemed an out-of-box failure.This component requires replacement.There was no patient involvement or adverse event 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: 7583515
• MDR Text Key: 110752901
• Report Number: 2249723-2018-00979
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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

• 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-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/08/2018
• Supplement Dates Manufacturer Received: 07/16/2018; 08/20/2018
• Supplement Dates FDA Received: 08/08/2018; 09/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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