MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-03 for ADAPTER BOX JACK W/DUMMY 8235NCEZ 8282 manufactured by Posey Products Llc.
[143972094]
Despite several attempts, the customer has not responded whether they will be returning the device. This event is reported solely on the initial information provided by the customer. Historical review of the complaint database found no other event with similar issue for this type of adapter. 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).
Patient Sequence No: 1, Text Type: N, H10
[143972095]
Customer reported when the nurse call cable is plugged into the adaptor it does not have a tight fit causing it to release on its own with little pulling or movement. The date the issue was discovered is unknown and no patient incident or injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2019-00126 |
| MDR Report Key | 8577509 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-03 |
| Date of Report | 2019-06-03 |
| Date Mfgr Received | 2019-06-03 |
| Date Added to Maude | 2019-05-03 |
| 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 | 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 | ADAPTER BOX JACK W/DUMMY |
| Generic Name | MONITOR, BED PATIENT |
| Product Code | KMI |
| Date Received | 2019-05-03 |
| Model Number | 8235NCEZ |
| Catalog Number | 8282 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-05-03 |