FDA Adverse Event
Malfunction
Summary report: N
SITTER SELECT
MDR report key: 3770344
·
Received February 18, 2014
Report
- Report Number
- 2020362-2014-00048
- Event Type
- Malfunction
- Date Received
- February 18, 2014
- Report Date
- January 13, 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
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: EVAL OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE, THE ALARM POWERS UP AND PASSES ALL FUNCTIONAL TESTS, THE ALARM SOUNDS AS IT SHOULD. HOWEVER, THE BATTERY SPRING TABS ARE BENT. CASE IS CHIPPED NEAR THE BATTERY DOOR. LIQUI-LABEL IS MISSING. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED THE ALARM HAS POWER BUT WILL NOT SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR. CUSTOMER DID NOT PROVIDE A DATE WHEN THIS ISSUE WAS DISCOVERED. NO PT INCIDENT OR INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103482 | SITTER SELECT | KMI | J. T. POSEY CO. | 8361 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | OVER-THE-MATTRESS SENSOR PAD, MODEL: 8307, LOT#UNK |