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 03/02/2022

Event Type  malfunction  

Manufacturer Narrative

Communication/interviews: the customer performed initial troubleshooting over the phone and was unable to power up the unit even while plugged in and verified that the batteries were properly seated in the battery bays.It was discussed on how to make sure that the console was appropriately engaged in the hospital cart.At this time, the customer has not requested for getinge to evaluate the cardiosave intra-aortic balloon pump (iabp) unit involved in this event.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during use the cardiosave intra-aortic balloon pump (iabp) unit would not charge.The customer switched out the iabp unit for another iabp unit to continue therapy without issue.It was recommended that the unit be tagged for biomed to evaluate.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

After further investigation, it was identified that this complaint event has been reported already under mfg report number 2249723-2022-00689.Please refer to mfg report number 2249723-2022-00689 for all information for this complaint event.Please cancel this mfg report number in your database.Revert all sections to blank : b.Adverse event or product problem.D.Suspect medical device.E.Initial reporter.G.All manufacturers.H.Device manufacturers only.

Event Description

After further investigation, it was identified that this complaint event has been reported already under mfg report number 2249723-2022-00689.Please refer to mfg report number 2249723-2022-00689 for all information for this complaint event.Please cancel this mfg report number in your database.

• 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: 13942760
• MDR Text Key: 290453369
• Report Number: 2249723-2022-00673
• 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: 01/12/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INTRA-AORTIC BALLOON.
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 59 KG