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

Model Number 0998-00-0800-45

Device Problem No Device Output (1435)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) unit would not print.The nurse called for assistance because they could not print from the pump printer.They made multiple attempt to print by changing the paper, and flipping but were unable.It was advised that i would help with switching pumps if they wished, but that the pump should function fine without the printer.

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) unit would not print.The nurse called for assistance because they could not print from the pump printer.They made multiple attempt to print by changing the paper, and flipping but were unable.It was advised that i would help with switching pumps if they wished, but that the pump should function fine without the printer.There was no patient harm reported.

Manufacturer Narrative

Corrected data: b5, h6 (clinical & impact).

Manufacturer Narrative

A getinge field service engineer was not dispatched to repair the unit as service/repair has not been requested.It is unknown if the unit was cleared for clinical use.If additional information becomes available, a supplemental report will be submitted.H3 other text : customer did not request service.

Event Description

N/a.

Manufacturer Narrative

It was reported that the cardiosave intra-aortic balloon pump (iabp) "could not print from the pump printer".(b)(6) called because they could not print from the pump printer.Getinge fse suggested and made multiple attempt to print by changing the paper, and flipping but were unable.Fse suggested that she report the pump to their biomed department for further service.Advised that i would help with switching pumps if she wished, but that the pump should function fine without the printer.She will discuss with the med staff and had no more questions.Information was taken for a complaint and she will let her biomed department know about the issue.Unit cleared for clinical use is unknown.There was no patient harm and no adverse event reported.If additional information becomes available, a supplemental report will be submitted.

• Brand Name: CARDIOSAVE HYBRID, TYPE I 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: 17412992
• MDR Text Key: 320293524
• Report Number: 2249723-2023-03416
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108421
• UDI-Public: 10607567108421
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-45
• Device Catalogue Number: 0998-00-0800-45
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 63 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 72 KG