MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) instructed the customer over the phone to reseat the cardiosave into the cart and ensure that the unit was plugged into ac power supply.The customer followed the instructions and let the unit charge for 3 hours.Subsequently, the stm called back to the customer to verify the unit operation.The customer informed that the iabp powered up properly.The service was completed and resolved over the phone.

Event Description

It was reported that during a pre-use check, cardiosave intra-aortic balloon pump (iabp) would not turn on when the power switch was depressed and the battery power leds would not energize.There was no patient involved, and no adverse event was reported.

Event Description

It was reported that during a pre-use check, cardiosave intra-aortic balloon pump (iabp) would not turn on when the power switch was depressed and the battery power leds would not energize.There was no patient involved, and no adverse event was reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6 (evaluation method codes), h10.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 10299005
• MDR Text Key: 199696620
• Report Number: 2249723-2020-01112
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

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?: No
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 07/28/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1