FDA Adverse Event
Malfunction
Summary report: N
KEEPSAFE DELUXE
MDR report key: 4260938
·
Received November 15, 2014
Report
- Report Number
- 2020362-2014-00360
- Event Type
- Malfunction
- Date Received
- November 15, 2014
- Report Date
- October 15, 2014
- 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
Additional Manufacturer Narrative · 1
RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THERE IS BATTERY CORROSION ON THE BATTERY CONTACTS INSIDE THE ALARM CASE. THE UNIT WAS TESTED WITH BATTERIES INITIALLY, THERE WAS NO POWER. WHEN THE BATTERIES WERE MOVED INSIDE THE ALARM CASE, THE UNIT POWERED ON. BATTERY LEAKAGE DOES NOT ALLOW THE BATTERIES TO HAVE PROPER CONNECTION WITH THE BATTERY CONTACTS. ONCE POWERED ON, THE ALARM PASSES ALL FUNCTIONAL TESTS. NOTE: INSTRUCTIONS FOR USE ON BATTERY REPLACEMENT STATES: (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED THE ALARM HAS POWER BUT SOMETIMES IT SOUND AND SOMETIMES IT DOES NOT. CUSTOMER REPORTED THIS WAS DISCOVERED DURING SET UP, BUT COULD NOT PROVIDE THE DATE OF EVENT. NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 740412 | KEEPSAFE DELUXE | KMI | J. T. POSEY CO. | 8374 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | OVER-THE-MATTRESS SENSOR MODEL: 8307, LOT# UNK |