FDA Adverse Event
Death
Summary report: N
PATIENT INFORMATION CENTER IX
MDR report key: 13227755
·
Received January 11, 2022
Report
- Report Number
- 1218950-2022-00042
- Event Type
- Death
- Date Received
- January 11, 2022
- Date of Event
- December 20, 2021
- Manufacturer
- PHILIPS NORTH AMERICA LLC
- Product Code
- MHX
- UDI-DI
- 00884838093041
- PMA / PMN Number
- K153702
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A PHILIPS REMOTE CLINICAL SPECIALIST (RCS) TALKED TO THE CUSTOMER TO TROUBLESHOOT THE ISSUE. THE RCS PULLED THE CLINICAL AUDIT LOG WHICH REVEALED THAT NO MALFUNCTION OCCURRED. THE AUDIT LOGS SHOWED THAT THE SYSTEM ALARMED AND THAT THE CUSTOMER ACKNOWLEDGED THE ALARMS DURING THE PATIENT EVENT. THE DEVICE REMAINS ONSITE AND IN USE.
Description of Event or Problem · 0
THE CUSTOMER REPORTED THAT THEY DID NOT HEAR A DESATURATION ALARM AND A PATIENT DIED ON (B)(6) 2021 AT 10:30 PM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 687395 | PATIENT INFORMATION CENTER IX | PATIENT INFORMATION CENTER IX | MHX | PHILIPS NORTH AMERICA LLC | 866389 | 00884838093041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Male | Death |