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

Model Number 0998-00-0800-53

Device Problem Failure to Charge (1085)

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

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during preventive maintenance (pm), the getinge service territory manager (stm) found that the cardiosave intra-aortic balloon pump (iabp) was not charging the batteries lithium battery packs.It was noticed when the cart was plugged in, the console would indicate that it can identify the battery by illuminating the battery position number.However, there the leds would not blink to indicate the batteries were charging.Also, iabp would not work on battery power.There was no patient involvement reported.

Manufacturer Narrative

Updated fields: b4,d9,g3,g6,h2,h3,h4,h6(type of investigation, investigation findings, component codes,investigation conclusions), h10.It was reported that during preventive maintenance done by a getinge field service engineer (fse) the cardiosave intra-aortic balloon pump (iabp) had batteries not charging.Fse found that surface mount chip was defective on power management board.Fse replaced power management pcb 0670-00-1162 and verified the charging of the unit.Fse completed ful pm and then tested the safety and functionality as per factory specifications and iabp was then returned to customer for clinical use.

Event Description

N/a.

• 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
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 18257594
• MDR Text Key: 329618561
• Report Number: 2249723-2023-05155
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/01/2023

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/04/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.