MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-04-14 for POSEY BED 8060 manufactured by J.t. Posey Company.
[5674005]
Customer reported a patient was able to put his finger through a hole in the netting and unlatch the buckle and unzip the zipper. The patient then fell out of the bed. The patient was not seriously injury and suffered only minor bruising.
Patient Sequence No: 1, Text Type: D, B5
[13142993]
The product has been requested to be returned but has not yet been received. The instructions for use has warning statement saying to ensure all zippers are closed appropriately and the quick release buckles on the zippers are latched before leaving a patient alone in the canopy. The user should test that all zippers are securely closed by putting pressure on the closed window zippers before leaving the patient. The bed must be inspected for any holes, rips, tears in any portion of the netting or material if any damages are seen the canopy must be taken out of use. Note: customer did not provide a serial number of this canopy therefore, the age of the product at the time of the issue is unknown. Product is pending to be returned.
Patient Sequence No: 1, Text Type: N, H10
[26873695]
Evaluation of the returned bed found the patient access window zipper slider crown and pull tab were broken off and missing. There were elastic tears in the leg covers on both sides of the canopy. Per the instructions for use:? The posey bed 8060 must be inspected each time before leaving the patient? S bedside. Always remove the patient from a damaged posey bed and remove it from service to prevent serious injury or death. Notify an authorized posey representative for information about repairs. Never use the posey bed if there is damage to the canopy, access panels or zippers. A failure to heed this warning may result in patient escape or unassisted bed exit, which may lead to serious injury or death from a fall. Always check the canopy and the zippers before leaving the patient alone to help reduce the risk of a fall or unassisted bed exit. Posey beds are multi-use, serviceable items. As such, it is expected that the units may occasionally require repair. The intervals at which canopies require repair are largely determined by use conditions. Because usage varies, the instructions for use require that beds be inspected prior to each use. If damage is noted during these routine bed inspections, the unit should not put into use with a patient and should be returned to posey for servicing. In this case, it was reported that a (b)(6) year old male intentionally caused the damage to the bed in order to escape the canopy. It is possible that an excessive amount of force was applied to the pull tab, which caused the slider crown to break off. The device was 30 months old at the time of the event and had never been returned for servicing. As evidenced by the patient being able to pry his finger into a preexisting hole in the netting and the multiple areas of damage noted during evaluation of the canopy, the device likely should have been returned for servicing prior to the event. The instructions for use were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. 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.
Patient Sequence No: 1, Text Type: N, H10
[26873696]
Supplemental required for product evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2015-00039 |
| MDR Report Key | 4690202 |
| Report Source | 05,06,07 |
| Date Received | 2015-04-14 |
| Date of Report | 2015-06-26 |
| Date of Event | 2014-10-17 |
| Date Mfgr Received | 2015-06-26 |
| Device Manufacturer Date | 2012-09-05 |
| Date Added to Maude | 2015-04-14 |
| 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 | MR, WILLIAM HINCY |
| Manufacturer Street | 5635 PECK RD. |
| 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 BODEGA 64 COLONIA RIO 3RA ETAP |
| Manufacturer City | BAJA CALIFORNIA, TIJUANA MEXICO 22226 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 22226 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSEY BED 8060 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2015-04-14 |
| Returned To Mfg | 2015-06-26 |
| Model Number | 8060 |
| Catalog Number | 8060 |
| Operator | RISK MANAGER |
| Device Availability | R |
| Device Age | DA |
| 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 | 2015-04-14 |