FDA Adverse Event
Malfunction
Summary report: N
RADLINK
MDR report key: 1150083
·
Received August 6, 2008
Report
- Report Number
- 1150083
- Event Type
- Malfunction
- Date Received
- August 6, 2008
- Report Date
- August 6, 2008
- Manufacturer
- MASIMO CORPORATION
- Product Code
- LNX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- DC, US
Narratives
Description of Event or Problem · 1
AS IT IS DESIGNED, THERE SHOULD BE A 5 SECOND DELAY BETWEEN THE ALARM CONDITION AND WHEN THE NOTIFICATION PAGE IS SENT. IF THERE IS ONLY 1 PAGER ASSIGNED TO THE PULSE OXIMETER, THE SYSTEM BEHAVES OK. IF THERE ARE MULTIPLE PAGERS (I.E. ASSIGNED BACKUP NURSE) THERE IS A 7 SECOND DELAY BETWEEN EACH PAGE REQUEST). DEPENDING UPON WHICH PAGER THE PRIMARY NURSE WAS HOLDING, THERE COULD BE A SEVERAL SECOND DELAY BEFORE THEY GET THE INITIAL PAGE. ANOTHER AREA OF THE HOSPITAL IS RUNNING THE SAME SOFTWARE VERSION WITH THE SAME ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADLINK | SOFTWARE, MONITOR PAGING | LNX | MASIMO CORPORATION | RADLINK | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |