FDA Adverse Event
Malfunction
Summary report: N
SITTER II
MDR report key: 3932858
·
Received March 11, 2014
Report
- Report Number
- 2020362-2014-00074
- Event Type
- Malfunction
- Date Received
- March 11, 2014
- Report Date
- February 14, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION CODES: RESULTS: (OTHER) - EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE. THE UNIT POWERS UP, BUT THE ALARM DOES NOT SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD. THE RED LED LOW BATTERY INDICATOR WORKS AS IT SHOULD, BUT , THE FAIL SAFE DOES NOT WORK. THE NURSE CALL LIGHT TURNS OFF INTERMITTENTLY AT THE NURSE CALL TEST FIXTURE WHEN THE NURSE CALL TEST FIXTURE WHEN THE NURSE CALL CABLE IS WIGGLED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE ALARM HAS POWER, BUT DOES NOT SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR. ALSO, THE LED LIGHT DOES NOT LIGHT UP. THE DATE WHEN THE ISSUE WAS DISCOVERED IS UNK. NO PT INCIDENT OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 146337 | SITTER II | KMI | J. T. POSEY CO. | 8281 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | BED SENSOR PAD: MODEL 8307, LOT # UNK |