FDA Adverse Event
Injury
Summary report: N
MX40 1.4 GHZ SMART HOPPING
MDR report key: 14166499
·
Received April 21, 2022
Report
- Report Number
- 1218950-2022-00355
- Event Type
- Injury
- Date Received
- April 21, 2022
- Date of Event
- March 31, 2022
- Manufacturer
- PHILIPS NORTH AMERICA LLC
- Product Code
- DSI
- UDI-DI
- 00884838082236
- PMA / PMN Number
- K113125
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 0
THE CUSTOMER REPORTS THAT THEY NEED A FIELD SERVICE ENGINEER (FSE) ONSITE TO REVIEW THE ALARM LOGS DUE TO AN UNKNOWN PATIENT INCIDENT.
Description of Event or Problem · 0
THE CUSTOMER REPORTS THAT THEY NEED A FIELD SERVICE ENGINEER (FSE) ONSITE TO REVIEW THE ALARM LOGS DUE TO A PATIENT INCIDENT. THE DEVICE WAS IN USE. PATIENT OUTCOME IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2005478 | MX40 1.4 GHZ SMART HOPPING | MX40 1.4 GHZ SMART HOPPING | DSI | PHILIPS NORTH AMERICA LLC | 865350 | 00884838082236 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |