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 Communication or Transmission Problem (2896)

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

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted when additional information is provided.

Event Description

It was reported by the flight nurse that an internal communication error alarm was displayed on the cardiosave intra-aortic balloon pump (iabp).Prior to call he had already attempted to reboot pump twice which did not work.As a result, he successfully switched consoles.The rn stated he would take pump out of service and mark for biomed.This pump was transferred and does not belong to this particular hospital.The rn stated he would handle the communication for surveillance.Limited information available.It is unknown the circumstances in which the event occurred or if there was patient involvement.No adverse event was reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, b6, b7, g4, g7, h2, h6 (type of investigation, component codes), h10, h11 corrected field: d4 (version or model#) testing of actual/suspected device (10) a getinge field service engineer (fse) was dispatched to evaluate the iabp.The fse i solated intermittent failure to coiled cable.To address the issue the fse replaced the coiled cable and replaced the expired battery modules.All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g4, g7, g8, h2, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected field: g1 (contact person ¿ mfg site), h4.

• 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: 12088464
• MDR Text Key: 265583244
• Report Number: 2249723-2021-01380
• 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,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• 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
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose