FDA Adverse Event
Malfunction
Summary report: N
SITTER II
MDR report key: 1893958
·
Received November 3, 2010
Report
- Report Number
- 2020362-2010-00321
- Event Type
- Malfunction
- Date Received
- November 3, 2010
- Report Date
- September 21, 2010
- 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
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE ALARM POWERS ON BUT THERE IS NO ALARM TONE. THE LIQUI LABEL IS MISSING. NOTE: POSEY INSTRUCTIONS FOR USE HAS A WARNING STATEMENT "IF THE UNIT IS SUBJECTED TO SEVERE MECHANICAL SHOCK SUCH AS DROPPING THE UNIT, OR IS SUBMERGED IN LIQUID, THE UNIT MAY STOP FUNCTIONING AS DESIGNED." (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE ALARM HAS NO POWER WHEN THEY REPLACED THE BATTERIES. THE CUSTOMER REPORTED THAT THERE WAS NO DAMAGE TO THE BATTERY DOOR, NO VISIBLE DAMAGE TO THE ALARM CASE AND NO LOOSE WIRES. THERE WAS NO PATIENT INCIDENT OR INJURY. INSPECTION OF THE PRODUCT FOUND THAT THE ALARM POWERS ON BUT HAS NO ALARM TONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SITTER II | KMI | J. T. POSEY CO. | 8281 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | SQUARE CHAIR SENSOR PAD: MODEL 8308, LOT# UNKNOWN |