FDA Adverse Event Malfunction Summary report: N

AUTOMATED IMPELLA CONTROLLER

MDR report key: 20641385 · Received November 8, 2024

Report

Report Number: 1220648-2024-22637
Event Type: Malfunction
Date Received: November 8, 2024
Date of Event: October 16, 2021
Report Date: November 8, 2024
Manufacturer: ABIOMED, INC.
Product Code: OZD
UDI-DI: 00813502010022
PMA / PMN Number: P140003
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

E1: NAME OF INITIAL REPORTER IS UNKNOWN. E2/E3: UNKNOWN. THE INVESTIGATION FOR THE REPORTED BATTERY FAILURE (RED ALARM) ISSUE HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS RECEIVED FROM THE CUSTOMER. IT WAS CONFIRMED THAT PERSISTENT BATTERY FAILURE (TRANSPORT CONNECTION BLOWN/MISSING) WAS NOT DUE TO A DISENGAGED BATTERY SWITCH. DUE TO LOW/ FLATLINED VOLTAGE, BATTERY 2 DATA IS UNAVAILABLE THROUGH ATA OR BQ SOFTWARE. WHEN CONSOLE WAS BOOTED FOR THE FIRST TIME, CONSOLE ALARMS ARE CONSISTENT WITH WHAT WAS SEEN IN THE FIELD. CONSOLE INTERIOR CONNECTIONS WERE CHECKED AND VERIFIED. WHEN VISUALLY INSPECTING THE BATTERIES AND CHARGER, IT WAS OBSERVED THAT ONE OF THE BATTERIES STATUS LEDS WERE COMPLETELY BLANK. FAILED BATTERY WAS CHECKED, OCV WAS MEASURED TO BE ~V2.9. COMPARED TO THE OTHER BATTERY WHERE THE MEASURED VOLTAGE WAS ~16V. THE DECLINE IN ALL CELL VOLTAGES OF BATTERY 2 IS UNDETERMINED. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

Description of Event or Problem · 0

THE COMPLAINANT REPORTED THE AUTOMATED IMPELLA CONTROLLER (AIC) EXPERIENCED A BATTERY FAILURE (RED ALARM). NO CLINICAL DETAILS REGARDING RESOLUTION OR PATIENT INVOLVEMENT/CONDITION WERE PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1881167	AUTOMATED IMPELLA CONTROLLER	CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS	OZD	ABIOMED, INC.	AUTOMATED IMPELLA CONTROLLER	1122628	00813502010022

Patients

Seq	Age	Sex	Outcome	Treatment
1	0 DA	Unknown