MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-01-18 for POSEY KEEPSAFE DELUXE 8374 manufactured by J. T. Posey Co..
[3439039]
Customer reported that the alarm has no power. Batteries have been replaced with a new supply. No visible battery acid leakage in the battery compartment. No visible damage to the outside of the case. The customer did not provide a date when this was discovered. There was no patient incident or injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10573960]
Evaluation codes: results: evaluation of the returned unit did not confirm no power. The unit was missing the battery door, the led lens on the front of the alarm sits uneven when compared to a known good unit, there is battery leakage residue at the bottom of a flat contact, the aquaqlert water indicator label shows moisture exposure and the rj- 11 pins in the alarm receptacle are corroded. The unit powered on and passed functional tests. Note: the instructions for use state: the posey keepsafe deluxe is an electronic device. It may fail to work if subjected to severe shock, such as being dropped, or immersed in liquid. Do not use the alarm and do not attempt to clean it if there are any signs of battery leakage such as corrosion, rust or white powder residue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020362-2013-00028 |
| MDR Report Key | 2969090 |
| Report Source | 06 |
| Date Received | 2013-01-18 |
| Date of Report | 2012-12-26 |
| Date Mfgr Received | 2013-01-16 |
| Device Manufacturer Date | 2011-02-01 |
| Date Added to Maude | 2013-04-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROXANA KOUSSA |
| Manufacturer Street | 5635 PECK RD. |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Manufacturer G1 | J. T. POSEY CO. |
| Manufacturer Street | 5635 PECK RD. |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSEY KEEPSAFE DELUXE |
| Product Code | KIM |
| Date Received | 2013-01-18 |
| Returned To Mfg | 2013-01-11 |
| Model Number | 8374 |
| Catalog Number | 8374 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J. T. POSEY CO. |
| Manufacturer Address | ARCADIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-18 |