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 Display or Visual Feedback Problem (1184); Device Difficult to Program or Calibrate (1496)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

At this time, the customer has not requested getinge to evaluate the iabp unit involved in this event.Attempts of communicating with the customer have been made to obtain further repair information.A supplement report will be submitted should additional information be provided.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) screen froze, whereby the touch screen touch pad buttons did not work.It was also reported that the customer attempted to switch the iabp unit on and off, without avail.Ultimately, it was reported that the customer swapped the unit without issue or harm to the patient, and the unit was sent to the customer's biomed department for evaluation.There was no patient harm, serious injury or adverse event was reported.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) screen froze, whereby the touch screen touch pad buttons did not work.It was also reported that the customer attempted to switch the iabp unit on and off, without avail.Ultimately, it was reported that the customer swapped the unit without issue or harm to the patient, and the unit was sent to the customer's biomed department for evaluation.There was no patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

Updated fields: b4, d4 (model#) g3, g6, h2, h6 (health effect ¿ clinical code, medical device - problem code, type of investigation, component codes, health effect - impact codes), h10, h11.Corrected fields: d1, d4 (catalog #, unique identifier (udi)#.Patient height: 186cm.

• 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 07430
• MDR Report Key: 11068253
• MDR Text Key: 224597510
• Report Number: 2249723-2020-02226
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108421
• UDI-Public: 10607567108421
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

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
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS SN# (B)(6)
• Patient Age: 70 YR
• Patient Weight: 87