FDA Adverse Event
Malfunction
Summary report: N
ECAREMANAGER
MDR report key: 1921028
·
Received December 8, 2010
Report
- Report Number
- 1125873-2010-00004
- Event Type
- Malfunction
- Date Received
- December 8, 2010
- Report Date
- December 8, 2010
- Manufacturer
- PHILIPS VISICU
- Product Code
- MSX
- PMA / PMN Number
- K012171
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
(B)(4) MESSAGES SENT BY THE HOSPITAL INFO SYSTEM BUT NOT YET REC'D AND PROCESSED BY ECAREMANAGER AT THE REMOTE MONITORING CENTER WILL BE LOST IF THE REMOTE SERVER PROCESSING THE MESSAGES FAILS OR IS RESTARTED. THE TYPE OF MESSAGES INVOLVED ARE COPIES OF MEDICATION ORDERS, ADMISSION/DISCHARGE/TRANSFER DATA, LABORATORY RESULTS, VITAL SIGN DATA, NURSING FLOWSHEET DATA, AND RESPIRATORY DATA. TYPICALLY, THE MESSAGES DO NOT QUEUE UNLESS THERE IS A PROBLEM WITH THE SERVER. THE USUAL RESOLUTION, HOWEVER, IT TO RESTART THE SERVER. THERE HAVE BEEN NO CUSTOMER COMPLAINTS OR REPORTS OF PT INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECAREMANAGER | CLINICAL DECISION-SUPPORT SOFTWARE | MSX | PHILIPS VISICU | V3.6 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |