FDA Adverse Event Malfunction Summary report: N

CARDIOSAVE HYBRID TYPE B PLUG

MDR report key: 16246400 · Received January 26, 2023

Report

Report Number: 2249723-2023-00490
Event Type: Malfunction
Date Received: January 26, 2023
Date of Event: August 24, 2021
Report Date: February 22, 2024
Manufacturer: DATASCOPE CORP. - MAHWAH
Product Code: DSP
UDI-DI: 10607567108391
PMA / PMN Number: K112372
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH
Reporter Occupation: NURSE
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

UPDATED FIELDS - (SITE COUNTRY), (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE. THE FSE EVALUATED THE IABP UNIT AND CONFIRMED THAT THE HINGES WERE BENT. THE FSE RESOLVED THE ISSUE BY REPLACING THE BOTH HINGES (0105-00-0138-02) (0105-00-0138-01) AND COVERS (0380-00-0561) (0380-00-0561). THE FSE PERFORMED FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE.

Additional Manufacturer Narrative · 0

THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

Description of Event or Problem · 0

N/A.

Description of Event or Problem · 0

IT WAS REPORTED THAT DURING A ROUTINE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SCREEN HINGES WERE BREAKING AND THE TOP DISPLAY WOULD NOT CLOSE PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
786250	CARDIOSAVE HYBRID TYPE B PLUG	SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL	DSP	DATASCOPE CORP. - MAHWAH	0998-00-0800-53		10607567108391

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown