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

Model Number UNKNOWN

Device Problems No Audible Alarm (1019); Unexpected Shutdown (4019)

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

Event Date 03/16/2022

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the nurse forgot to plug in the cardiosave intra-aortic balloon pump (iabp) after a trip to ct and the iabp shut down due to a dead battery.It was reported that there was no audible alarm.As a result, the customer emailed a company representative inquiring about normal behavior of low battery alarm.The iabp was reported to be exchanged for another and therapy was continued.There was no harm or injury to the patient and no adverse event was reported.

Manufacturer Narrative

Communication/interviews (4111): during a follow-up phone call with a getinge representative is when the user explained that the unit was switched out and there was no incident.The getinge representative explained in detail the normal behavior of the low battery alarm, instructions, and emailed her the battery quick reference guide.A supplemental report will be submitted upon receipt of additional information or completion of our investigation.Ussr called support.

Manufacturer Narrative

It was reported that performed by a the cardiosave intra-aortic balloon pump (iabp) had shutdown - unexpected unspecified.Customer reported normal behavior of low battery alarm.Iabp shut off due to a dead battery and the nursing staff was unaware for about 30 minutes.It was said that there was no audible alarm.They switched to the back up pump.There is not further information is available.There was patient involvement but no harm reported.As of now the investigation is closed, if any new information received in future related to part replacement will reopen the complaint and update it.

• Brand Name: UNKNOWN CARDIOSAVE INTRA-AORTIC BALLOON PUMP
• 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: 14087162
• MDR Text Key: 289772852
• Report Number: 2249723-2022-00812
• Device Sequence Number: 1
• Product Code: DSP
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: IAB CATHETER
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 79 KG