FDA Adverse Event Malfunction Summary report: N

HAMILTON-C1

MDR report key: 20505920 · Received October 22, 2024

Report

Report Number
3001421318-2024-02544
Event Type
Malfunction
Date Received
October 22, 2024
Date of Event
August 21, 2024
Report Date
November 19, 2025
Manufacturer
HAMILTON MEDICAL AG
Product Code
CBK
UDI-DI
07630002800747
PMA / PMN Number
K181216
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
HI, US
Reporter Occupation
OTHER
Health Professional
N

Narratives

Additional Manufacturer Narrative · 0

HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).

Description of Event or Problem · 0

THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: "ERROR CODE 233004" (AUTOZERO ERROR QAW/PAW). NO PATIENT IMPACT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2279339 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown