MAUDE Adverse Event Report: J.T. POSEY COMPANY POSEY BED 8060; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number 8060

Device Problem Insufficient Information (3190)

Patient Problem Bruise/Contusion (1754)

Event Date 10/17/2014

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Event Description

Supplemental required for product evaluation.

• Brand Name: POSEY BED 8060
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): J.T. POSEY COMPANY; 5635 peck rd; arcadia CA 91006
• Manufacturer (Section G): POSEY, S. DE R.L. DE C.V.; ave. ferrocarril no. 16901; bodega 64 colonia rio 3ra etap; baja california, tijuana mexico 2222 6
• Manufacturer Contact: william hincy ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4690202
• MDR Text Key: 5674005
• Report Number: 2020362-2015-00039
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Risk Manager
• Device Model Number: 8060
• Device Catalogue Number: 8060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 04/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 52