MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-08-05 for POSEY BED 8070 manufactured by J.t. Posey Company.
[51296790]
Evaluation of the returned bed confirmed that one tooth from the left side patient access panel was missing. The malfunction was repaired and returned back to the customer for use. The customer further reported that the patient that fell required stitches for a cut they received on the lip. Posey beds are multi-use, serviceable items. As such, it is anticipated that the units may occasionally require repair, and as part of standard care the beds should be inspected prior to use. If damage is noted during these routine bed inspections, the unit should not be put into use with a patient and should be returned to posey for servicing. If a zipper element is missing, it can allow for the unintentional opening of the canopy window. Applying pressure directly to the unsecured area will reveal the breach, which is why the user manual advises caregivers to apply direct pressure along the entire length of the zipper. Although the cause of the missing element cannot be confirmed, it is possible that excessive use or normal wear and tear could have attributed to the damage. Of note, the canopy was over 24 months old when it was received in for service. Service issues are trended and reviewed by management on a monthly basis. As part of this monthly review, trends and excursions above control limits will be assessed, documented and acted upon as warranted. No corrective or preventative actions are necessary at this time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[51296791]
Customer reported the zipper teeth are not-aligned and the zipper is jagged throughout the zipper tape. The spacing between teeth are torn and pulled out of place. The panel zipper opened up and the patient fell out of the canopy. The customer confirmed the patient suffered injuries to his lip requiring stitches to his lip. The exact date is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2016-00025 |
| MDR Report Key | 5851152 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-08-05 |
| Date of Report | 2016-07-11 |
| Date Mfgr Received | 2016-07-11 |
| Device Manufacturer Date | 2013-03-22 |
| Date Added to Maude | 2016-08-05 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| 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 |
| Manufacturer G1 | POSEY, S. DE R.L. DE C.V. |
| Manufacturer Street | AVE. FERROCARRIL NO. 16901. BO COLONIA RIO TIJUANA, 3RA. ETAP |
| Manufacturer City | TIJUANA 22664 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22664 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSEY BED 8070 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2016-08-05 |
| Returned To Mfg | 2016-07-21 |
| Model Number | 8070 |
| Catalog Number | 8070 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER CAREGIVERS |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J.T. POSEY COMPANY |
| Manufacturer Address | 5635 PECK RD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-05 |