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

Model Number N/A

Device Problem Failure to Charge (1085)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and was able to verified that the console is poorly connected to the cart."rescue mode" causing the batteries not to charge due to lack power.The unit was check and functional test was carried out when issue was corrected.The iabp was returned to the customer and cleared for clinical us.(b)(6).

Event Description

It was reported that before therapy, the battery will not charge the cardiosave intra-aortic balloon pump (iabp).There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The device history record (dhr) for this iabp unit with serial number (b)(6) was reviewed and no non-conformances related to the reported event were noted.

Event Description

It was reported that before therapy, the battery will not charge the cardiosave intra-aortic balloon pump (iabp).There was no patient involvement, and no adverse event reported.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• MDR Report Key: 11565500
• MDR Text Key: 243382081
• Report Number: 2249723-2021-00605
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• 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: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/11/2021
• Patient Sequence Number: 1