FDA Adverse Event
Malfunction
Summary report: N
SITTER SELECT
MDR report key: 3810667
·
Received March 24, 2014
Report
- Report Number
- 2020362-2014-00099
- Event Type
- Malfunction
- Date Received
- March 24, 2014
- Report Date
- February 11, 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE; UNIT POWERS UP AND WHEN SET ON HOLD THE ALARM IS NOT CONTINUOUS. HOWEVER, THE BATTERY SPRINGS INSIDE THE BATTERY COMPARTMENT ARE BENT, CASE IS CRACKED ON BATTERY DOOR, AND WARNING LABEL IS TORN. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE ALARM CONTINUOUSLY SOUNDS WHEN THE ALARM IS PLACED ON HOLD MODE. CUSTOMER REPORTED THIS WAS FOUND DURING SET UP BUT COULD NOT PROVIDE A DATE WHEN FOUND. NO PT INCIDENT OR INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172516 | SITTER SELECT | KMI | J. T. POSEY CO. | 8361 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | SQUARE CHAIR SENSOR PAD: MODEL 8308, LOT # UNK |