POSEY KEEPSAFE DELUXE
Report
- Report Number
- 2020362-2013-00248
- Event Type
- Malfunction
- Date Received
- June 4, 2013
- Report Date
- May 9, 2013
- Manufacturer
- J. T. POSEY CO.
- Product Code
- KMI
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
RESULTS: REPORTED ISSUE IS CONFIRMED, THE VOICE MESSAGE PLAYS WITH STATIC WHEN SET TO VOICE AND TONE. VISUAL INSPECTION FOUND THAT THERE IS CORROSION FROM BATTERY LEAKAGE ON FLAT CONTACTS AND A BATTERY DOOR IS MISSING. NOTE: THE INSTRUCTIONS FOR USE HAS A STATEMENT: TAKE CARE WHEN INSTALLING NEW BATTERIES. THE ALARM WILL NOT WORK IF BATTERIES ARE INSTALLED IMPROPERLY. ALWAYS INSTALL A COMPLETELY NEW SET OF BATTERIES WHEN THE CHIRPING DUE TO LOW BATTERY POWER SOUND BEGINS. DO NOT REPLACE A SINGLE CELL, BUT ALL CELLS IN THE ALARM. DO NOT MIX OLD AND NEW BATTERIES, OR BATTERY BRANDS WITHIN A BATTERY PACK (4 BATTERIES). USE OF MIXED BATTERIES OR BATTERIES INSTALLED INCORRECTLY MAY CAUSE BATTERY DAMAGE, AND MAY DAMAGE THE ALARM. REMOVE ANY ALARM FROM USE AND SEND TO THE APPROPRIATE FACILITY AUTHORITY IF BATTERIES ARE DAMAGED OR CORRODED OR THE BATTERY COMPARTMENT HAS SIGNS OF PREVIOUS BATTERY CORROSION SUCH AS WHITE POWDER RESIDUE. (B)(4).
CUSTOMER REPORTED WHEN THE ALARM IS SET TO VOICE ONLY MODE THAT STATIC CAN BE HEARD. THE CUSTOMER DID NOT PROVIDE THE DATE WHEN THE ISSUE WAS FOUND. NO PT INCIDENT OR INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 247604 | POSEY KEEPSAFE DELUXE | KMI | J. T. POSEY CO. | 8374 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | OVER-THE-MATTRESS SENSOR PAD: MODEL 8307, LOT# UNK |