MAUDE Adverse Event Report: POSEY COMPANY POSEY BED 8070; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number 8070

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Results: evaluation of the returned product found an open zipper slider on the left side window of a patient access area which would not allow proper element closure.Delamination of the mattress envelope on the right side panel was also noted.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 put into use with a patient and should be returned to posey for servicing.If the zipper slider body is bent open (i.E., the mouth is wider than manufacturing specifications) it can prevent the slider from properly engaging the zipper teeth.In areas where the slider engages the teeth, the zipper is secure and cannot be opened.However, if the teeth do not engage it can potentially leave an unsecured area.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.In order for an open slider to potentially contribute to patient egress, the following must occur: the slider does not engage the teeth, the caregiver does not properly check the zipper prior to leaving the patient unattended, and the patient identifies the unsecured area and exits the bed.Following the ifu and standard servicing protocols, the user can identify any open sliders prior to use and return the bed for repair.In this case, there was no impact or consequence to the patient and the canopy was returned for servicing when the zipper issues were identified.Although the cause of the open slider cannot be confirmed, the canopy was approximately 40 months old and there was evidence of improper laundering (material delamination).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.Note: instructions for use states: 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.Never rip the panels open, as this will damage the zipper slider, preventing the zipper from closing completely.Before leaving the patient alone, apply pressure with your hands along the entire length of the zipper to make sure the panel is completely closed and that there are no gaps or openings along the entire length of each zipper.(b)(4).

Event Description

Customer reported damage to the zipper located on the left side panel.No patient incident or injury was reported and the customer did not know when the issue was discovered.

• Brand Name: POSEY BED 8070
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): POSEY COMPANY; 5635 peck road; arcadia CA 91006 0020
• Manufacturer (Section G): POSEY, S. DE R.L. DE C.V.; ave. ferrocarril no. 16901. bo; colonia rio tijuana, 3ra. etap; tijuana 22664 ; MX 22664
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 5005662
• MDR Text Key: 23123342
• Report Number: 2020362-2015-00060
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8070
• Device Catalogue Number: 8070
• Device Lot Number: 2012040905
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2012
• 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