FDA Adverse Event
Malfunction
Summary report: N
AGILITI/SIZEWISE OTHER - 2020
MDR report key: 20268124
·
Received September 19, 2024
Report
- Report Number
- MW5159788
- Event Type
- Malfunction
- Date Received
- September 19, 2024
- Report Date
- September 16, 2024
- Manufacturer
- AGILITI HEALTH - ELLIS
- Product Code
- FNM
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- NURSE
- Health Professional
- *
Narratives
Description of Event or Problem · 0
(B)(6) HCS 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: AGILITI/SIZEWISE OTHER - 2020 AREA FOUND TO BE COMPROMISED: INSIDE OF COVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1449440 | AGILITI/SIZEWISE OTHER - 2020 | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE | FNM | AGILITI HEALTH - ELLIS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |