FDA Adverse Event Malfunction Summary report: N

UMANO AIRNEST ORANGE - 2020

MDR report key: 20267773 · Received September 19, 2024

Report

Report Number
MW5159773
Event Type
Malfunction
Date Received
September 19, 2024
Report Date
September 16, 2024
Manufacturer
UMANO MEDICAL INC.
Product Code
FNM
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
NURSE
Health Professional
*

Narratives

Description of Event or Problem · 0

(B)(6) IS COMPLETING INSPECTIONS OF ALL HOSPITAL BED AND GURNEY SURFACES PER A NATIONAL PATIENT SAFETY ALERT. THE FOLLOWING WAS INSPECTED: EXTERNAL COVER, ZIPPER, INSIDE OF COVER, MICROHOLES, FAILURE-ODORS, INTERNAL MATERIALS, FIRE BARRIER. SURFACE FOUND TO BE COMPROMISED: UMANO AIRNEST ORANGE - 2020 AREA FOUND TO BE COMPROMISED: EXTERNAL COVER, INSIDE OF COVER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1309098 UMANO AIRNEST ORANGE - 2020 MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM UMANO MEDICAL INC.

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown