FDA Adverse Event
Malfunction
Summary report: N
DOLPHIN FIS
MDR report key: 21527205
·
Received March 5, 2025
Report
- Report Number
- 3009402404-2025-00009
- Event Type
- Malfunction
- Date Received
- March 5, 2025
- Date of Event
- February 3, 2025
- Report Date
- March 5, 2025
- Manufacturer
- JOERNS HEALTHCARE
- Product Code
- FNM
- UDI-DI
- 00857268006516
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT OR OTHER INFORMATION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND RELEASE BY FDA OF THAT REPORT INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY JOERNS HEALTHCARE , ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES, FINISHED DEVICE SUPPLIERS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
Description of Event or Problem · 0
IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT PER AGILITI - DOLPHIN MATTRESS KEEPS DEFLATING RESULTING IN PATIENT LAYING ON THE BED FRAME. NO INJURIES MENTIONED. AGILITI WILL PERFORM THE TESTING. COMPLAINT # (B)(4) WAS ENTERED INTO OUR SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2632262 | DOLPHIN FIS | PATIENT AIR MATTRESS | FNM | JOERNS HEALTHCARE | 900T-CU-U | 00857268006516 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |