FDA Adverse Event
Malfunction
Summary report: N
SITTER SELECT
MDR report key: 2123397
·
Received June 10, 2011
Report
- Report Number
- 2020362-2011-00204
- Event Type
- Malfunction
- Date Received
- June 10, 2011
- Report Date
- May 21, 2011
- 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
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - THE PRODUCT HAS BEEN REQUESTED TO BE RETURNED BUT HAS NOT BEEN RECEIVED. MFR REFERENCES FILE (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE ALARM HAS POWER, BUT NO ALARM TONE WHEN PRESSURE IS OFF THE PAD. THERE WAS NO DAMAGE TO THE ALARM REPORTED BY CUSTOMER. THERE WAS NO PT INCIDENT OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SITTER SELECT | KMI | J. T. POSEY CO. | 8361 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |