MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-55

Device Problem Failure to Read Input Signal (1581)

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

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

Type of investigation not yet determined: a supplemental report will be submitted if additional information is provided.Full event site name: (b)(6).

Event Description

It was reported that the touch screen in the cardiosave intra-aortic balloon pump (iabp) was not working.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp.The fse reported that compressor failures were detected upon review of the system, which indeed presented problems on the touch screen.Numerous tests were performed and some materials were replaced: the touch screen was replaced and calibration tests was performed.The fse informed that the compressor was replaced latter after it was received.The calibration of the pressure vacuum regulators and pneumatic performance tests of the compressor were carried out.As well as the whole set.The fse stated that the iabp is in correct working order.

Event Description

It was reported that the touch screen in the cardiosave intra-aortic balloon pump (iabp) was not working.It is unknown under which circumstances this event occurred.There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.

Manufacturer Narrative

Updated fields: b4, g3, g4, g7, g8, h2, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: d5, g1(contact person).

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID INT TYPE E/F 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: 12350717
• MDR Text Key: 267665382
• Report Number: 2249723-2021-01882
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; UNKNOWN.
• Patient Sex: Prefer Not To Disclose