FDA Adverse Event
Malfunction
Summary report: N
INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0
MDR report key: 10857428
·
Received November 17, 2020
Report
- Report Number
- 1218950-2020-06954
- Event Type
- Malfunction
- Date Received
- November 17, 2020
- Report Date
- November 9, 2020
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DXJ
- UDI-DI
- 00884838075153
- PMA / PMN Number
- K100272
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
THE CUSTOMER ALLEGED "DATA FROM SILICON (PHARMACY MEDICATION) ARE NOT BEING TRANSFERRED". NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1322770 | INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 | CLINICAL INFORMATION MANAGEMENT SYSTEM | DXJ | PHILIPS MEDICAL SYSTEMS | 866148 | 00884838075153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |