MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-13 for ALARM SENSOR, HOOK & LOOP ALARM BELT SENSOR 8372 manufactured by Posey Products Llc.
[138796721]
Additional information was received and customer reported device will not be returned. Since the device was not returned the reported issue could not be confirmed. This report is based solely on the customer reported issue. The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. The ifu states if the alarm and/or sensor do not function properly, remove the alarm and sensor from service and replace them with a properly functioning alarm and/or sensor. Do not use the alarm or sensor if it does not activate each time weight is removed from the sensor, or if the chair belt sensor is unfastened. At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device. Therefore, no corrective or preventative actions are necessary. All complaints are trended and reviewed by management on a monthly basis. As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted. Manufacturer reference file (b)(4). Device will not be returned.
Patient Sequence No: 1, Text Type: N, H10
[138796722]
The customer reported the posey hook and loop alarm belt sensor was being used with the posey sitter elite sitter elite alarm unit. The complaint indicated that once the belt was released, the alarm did not sound. The date the issue was discovered is unknown and no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2019-00030 |
| MDR Report Key | 8417761 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-13 |
| Date of Report | 2019-02-14 |
| Date Mfgr Received | 2019-02-14 |
| Date Added to Maude | 2019-03-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM HINCY |
| Manufacturer Street | POSEY COMPANY 5635 PECK ROAD |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALARM SENSOR, HOOK & LOOP ALARM BELT SENSOR |
| Generic Name | FALL PREVENTION ALARM/SENSOR ATTACHED ONLY |
| Product Code | PJP |
| Date Received | 2019-03-13 |
| Model Number | 8372 |
| Catalog Number | 8372 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 5635 PECK ROAD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-13 |