FDA Adverse Event
Death
Summary report: N
STANLEY UMP TIMED CHAIR SENTRY PAD (SIC)
MDR report key: 1194409
·
Received October 10, 2008
Report
- Report Number
- 1929691-2008-00004
- Event Type
- Death
- Date Received
- October 10, 2008
- Date of Event
- September 27, 2008
- Report Date
- October 1, 2008
- Manufacturer
- STANLEY SECURITY SOLUTIONS, INC. SENIOR TECHNOLOGIES DIV
- Product Code
- KMI
- PMA / PMN Number
- K924433
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
RISK MANAGER IS KEEPING POSSESSION OF SUSPECTED UNITS, THEREFORE, AN EVAL CAN NOT BE PERFORMED.
Description of Event or Problem · 1
THE RESIDENT FOUND ON FLOOR OF ROOM UNDER BED WITHOUT VITAL SIGNS. PRESSURE ALARM MALFUNCTIONED AND DID NOT ALARM WHEN THE RESIDENT GOT OUT OF BED. STAFF UNABLE TO MAKE ALARM SOUND FOLLOWING EVENT. (SIC). DISCUSSION CONDUCTED ON 10/2/08 WITH RISK MANAGER AT FACILITY STATED THAT THE EQUIPMENT WILL NOT BE SENT TO MANUFACTURER FOR EVAL, AND WILL REMAIN IN HER POSSESSION. RISK MANAGER REMARKED THAT THE EQUIPMENT CONTINUALLY BEEPS EVERY FEW SECONDS. SUSPECTED UMP EQUIPMENT MODEL#91600 AND/OR 93120.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STANLEY UMP TIMED CHAIR SENTRY PAD (SIC) | PRESSURE ALARM (SIC) | KMI | STANLEY SECURITY SOLUTIONS, INC. SENIOR TECHNOLOGIES DIV | UMP #91600 (SIC) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | UMP MONITOR MODEL #91600 (SIC) |