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

Model Number 0998-00-0800-53

Device Problem Device Alarm System (1012)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

Device not accessible for testing: (b)(4): device is not accessible for testing due to the customer not requesting repair service.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.No service requested.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) gave a gas loss alarm.The unit was swapped out with another to continue therapy.No patient harm, serious injury or adverse event was reported.

Event Description

N/a.

Manufacturer Narrative

A getinge field service engineer (fse) did not evaluated the iabp.It was determined by the customer that the unit did not malfunction but instead, the gas loss alarm was caused by the pt swallowing food.

• Brand Name: CARDIOSAVE HYBRID DOMESTIC
• 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: 12277250
• MDR Text Key: 265065845
• Report Number: 2249723-2021-01720
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

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: 07/13/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 104 KG