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 Zero (1683)

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

Event Date 12/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient height: 182.9cm.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) would no longer respond to the command to zero.It was also reported that troubleshooting revealed that the end user was doing everything correctly and that the transducer was connected directly to the iabp unit so the iabp unit would be taken to the biomed department.There was no harm or injury to the patient and no adverse event was reported.

Manufacturer Narrative

Additional contact details: phone number: (b)(6).At this time, the customer has not requested getinge to evaluate the iabp.Additional information was requested from the customer with regard to the repair and status of the iabp; however, despite our best efforts, no repair information and no status of the iabp has been received.If any pertinent information is received in the future, a supplemental report will be submitted.

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: 13285210
• MDR Text Key: 286515632
• Report Number: 2249723-2022-00114
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

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: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/24/2021
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 81 KG