FDA Adverse Event
Malfunction
Summary report: N
AGILITI/SIZEWISE 2012
MDR report key: 20267760
·
Received September 19, 2024
Report
- Report Number
- MW5159772
- 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 NP12 - 2012 AREA FOUND TO BE COMPROMISED: MICROHOLES, FIRE BARRIER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1449427 | AGILITI/SIZEWISE 2012 | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE | FNM | AGILITI HEALTH - ELLIS | NP12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |