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 Problems Failure to Charge (1085); Overheating of Device (1437); Unexpected Shutdown (4019)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2024

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was overheating and shutting off.There was no harm reported.

Manufacturer Narrative

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

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate the issue.The fse found the unit on a patient and customer couldn¿t take the unit out of service so the visit was rescheduled to the next day.Upon arrival onsite again the fse found batteries charging correctly on different outlet and verified outlet in the patient room was faulty.There was no fault found with the unit.The unit passed all functional and safety test per factory specifications, and it was returned to the customer and cleared for use.

Event Description

Initially, it was reported that during a routine check by the customer, the cardiosave intra-aortic balloon pump (iabp) was overheating and shutting off.Once on site, it was reported to the getinge feld service engineer (gfse) that the complaint is that batteries weren¿t charging and completely depleted.There was no overheating issue.There was no patient injury reported.

Manufacturer Narrative

Corrected data: b5, h6 (clinical, problem and impact code).Updated data: b4, g3, g6, h2, h10, h11.

Event Description

Initially, it was reported that during a routine check by the customer, the cardiosave intra-aortic balloon pump (iabp) was overheating and shutting off.Once on site, it was reported to the getinge feld service engineer (gfse) that the complaint is that batteries weren¿t charging and completely depleted.There was no overheating issue.

• 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: 18921864
• MDR Text Key: 337875580
• Report Number: 2249723-2024-01129
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1