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 Electrical /Electronic Property Problem (1198); Battery Problem (2885)

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

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

Communication/ interviews, device not accessible for testing (4111, 4117 / 3233): a getinge field service engineer (fse) was contacted over the phone to provide a diagnosis.After hearing the run time specified for the batteries the customer declined service intervention at this time.The fse advised the customer to ensure the device remained connected to the a/c power and advised the customer to ensure the pump console was fully seated in the hospital cart.The customer was also advised to ensure the a/c sine wave led on the hospital cart was illuminated and the battery led was flashing while the batteries were charging.The customer confirmed the device was connected to a/c power at this time and the batteries were charging.The customer again declined service intervention at this time.The fse advised the customer to contact getinge with any additional questions or concerns regarding their device.A supplemental report will be submitted upon completion of our investigation.Not returned to manufacturer.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a battery that only lasted 1.45hrs.There was no harm or injury to the patient and no adverse event was reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h10, h11.Corrected fields; h6 (medical device ¿ problem code).The getinge field service engineer (fse) has reported that the customer continued to use the iabp unit after the phone conversation.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: g1(contact person).

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: 13043818
• MDR Text Key: 282629992
• Report Number: 2249723-2021-02907
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 12/20/2021; 06/23/2022
• Supplement Dates FDA Received: 01/10/2022; 06/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/29/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1