MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-07-27 for ALARM SENSOR, 30-DAY BED SENSOR PAD 8283 manufactured by .
[115683017]
This device was previously reportable under the (b)(4), which was revoked on (b)(6) 2018, resulting in this mdr submission. The device was not returned even after multiple attempts. This event is reported solely on the information provided by the customer. An investigation of similar complaints revealed several potential causes, including damages to either the alarm sensor receptacle or the sensor rj-11 clip. Damage to the sensor receptacle can cause the pins inside to become stuck down, either triggering no alarm or false alarm. It can also cause the sensor cable to not have a secure fit with the receptacle, allowing for movement to affect the function. Likewise with damage to the sensor cable clip. Other causes, such as corrosion and moisture damage, are also a possibility. Without the return of the device reported issue could not be confirmed. 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 warning 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 warrant. (b)(4). Product will not be returning.
Patient Sequence No: 1, Text Type: N, H10
[115683018]
Customer reported a patient got up off the sensor and the alarm did not sound. The sensor was disposed of. It is unsure if the patient suffered any injuries or if medical intervention was necessary. The date the issue was discovered is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00082 |
| MDR Report Key | 7728923 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-27 |
| Date of Report | 2018-04-20 |
| Date Mfgr Received | 2018-04-20 |
| Date Added to Maude | 2018-07-27 |
| 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, 30-DAY BED SENSOR PAD |
| Generic Name | MONITOR, BED PATIENT |
| Product Code | KMI |
| Date Received | 2018-07-27 |
| Model Number | 8283 |
| Catalog Number | 8283 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-27 |