FDA Adverse Event
Malfunction
Summary report: N
INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0
MDR report key: 11077692
·
Received December 28, 2020
Report
- Report Number
- 1218950-2020-08107
- Event Type
- Malfunction
- Date Received
- December 28, 2020
- Report Date
- December 16, 2020
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DXJ
- UDI-DI
- 00884838075153
- PMA / PMN Number
- K100272
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER DID NOT PROVIDE SERIAL NUMBER. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER REPORTING AN ERROR CONCERNING INFUSION PUMP MANAGEMENT . DOCUMENTATION SHOWS THE PATIENT RECEIVED LESS OF A DOSE THAN THEY SHOULD HAVE WHICH COULD HAVE CAUSED HARM TO THE PATIENT OR OTHER PATIENTS. THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1539611 | INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 | CLINICAL INFORMATION MANAGEMENT SYSTEM | DXJ | PHILIPS MEDICAL SYSTEMS | 866148 | 00884838075153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |