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 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to evaluate the iabp and was able to confirm the reported issue. The stm was able to verify that the iabp was charging in both slots by placing known good batteries in each and discovered that the defective battery would not charge in either slot. To address the issue the stm replaced the battery and performed all functional and safety tests which passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service. (b)(6).

Event Description

It was reported that the batteries will not charge when the cardiosave intra-aortic balloon pump (iabp) is plugged into ac. When plugged into ac the ac green light comes on but the battery charging light does not come on and the batteries are not being charged. It is unknown under which circumstances this event occurred; however there was no patient involvement and no adverse event was reported.

• 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
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 10290092
• MDR Text Key: 199312859
• Report Number: 2249723-2020-01103
• 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,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse