FDA Adverse Event Injury Summary report: N

HAMILTON G5 #21

MDR report key: 9166351 · Received October 7, 2019

Report

Report Number
MW5090248
Event Type
Injury
Date Received
October 7, 2019
Date of Event
September 26, 2019
Report Date
October 3, 2019
Manufacturer
HAMILTON MEDICAL AG / HAMILTON MEDICAL, INC.
Product Code
CBK
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
NO INFORMATION

Narratives

Description of Event or Problem · 1

VENT ARM BUMPED SCREEN CAUSING IT TO GO BLANK AND CONTINUOUSLY ALARM; VENTILATOR STILL WORKING PROPERLY. VENT PULLED FROM SERVICE, SENT FOR INVESTIGATION OF ISSUE. NO HARM TO PT. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
957907 HAMILTON G5 #21 VENTILATOR, CONTINUOUS, FACILITY USE CBK HAMILTON MEDICAL AG / HAMILTON MEDICAL, INC. G5

Patients

Seq Age Sex Outcome Treatment
1 67 YR Required Intervention