FDA Adverse Event
Malfunction
Summary report: N
SIMPLYGO MINI
MDR report key: 18157464
·
Received November 17, 2023
Report
- Report Number
- 2518422-2023-30816
- Event Type
- Malfunction
- Date Received
- November 17, 2023
- Date of Event
- October 31, 2023
- Report Date
- August 2, 2024
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CAW
- PMA / PMN Number
- K131982
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
H3 OTHER TEXT : DEVICE EVALUATED BY PHILIPS FIELD SERVICE ENGINEER.
Additional Manufacturer Narrative · 0
THE UDI IN SECTION D4 WAS PREVIOUSLY REPORTED IN THE INCORRECT FORMAT. THE UDI INFORMATION HAS BEEN UPDATED TO THE CORRECT FORMAT.
Description of Event or Problem · 0
THE MANUFACTURER RECEIVED INFORMATION ALLEGING ISSUES WITH A SIMPLYGO MINI,EXTENDED BATTERY. THERE WAS NO REPORT OF SERIOUS HARM OR INJURY. THE MANUFACTURER RECEIVED THE DEVICE FOR INVESTIGATION. THE MANUFACTURER CONFIRMED THE COMPLAINT AND REPLACED 1131554B, 1131550B, 1140694B, 1132383, AND 1132519. FOUND SIEVE BEDS WITH LOW O2, AIRSIDE MANIFOLD CHIRPING, O2 SIDE CHECK VALVES MALFUNCTIONING, INLET FILTER PM, TUBING WORN, POWER CONNECTOR CHARGE PORT BROKEN. UPDATED SIMPLYGO MINI SOFTWARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292574 | SIMPLYGO MINI | GENERATOR, OXYGEN, PORTABLE | CAW | RESPIRONICS, INC. | 1113601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |