FDA Adverse Event
Malfunction
Summary report: N
DOLPHIN FIS
MDR report key: 20346007
·
Received October 1, 2024
Report
- Report Number
- 3009402404-2024-00041
- Event Type
- Malfunction
- Date Received
- October 1, 2024
- Date of Event
- August 29, 2024
- Report Date
- September 29, 2024
- Manufacturer
- JOERNS HEALTHCARE
- Product Code
- FNM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT OR OTHER INFORMATION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND 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 THE DOLPHIN MATTRESS WAS NOT STAYING INFLATED WHILE PATIENT WAS ON THE MATTRESS. NO PATIENT INJURY. COMPLAINT #(B)(4) WAS ENTERED INTO OUR SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2351892 | DOLPHIN FIS | PATIENT AIR MATTRESS | FNM | JOERNS HEALTHCARE | 900TLP-3582-M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |