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

Model Number 8070

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2015

Event Type  malfunction  

Event Description

Customer reported the zipper will no longer zip up.This was discovered while in use and there was no patient injury reported.

Manufacturer Narrative

Inspection of the unit found an open zipper slider on the patient access window.In addition, the mattress envelope was delaminated, there was a 1 inch netting tear, and the zipper pull tab was missing on the leg of the head panel.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: 1) the slider does not engage the teeth, 2) the caregiver does not properly check the zipper prior to leaving the patient unattended, and 3) 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, it is possible that an excessive amount of force was applied to the pull tab, which could have bent the slider body open.Of note, the canopy was 40 months old, an excessive amount of damage was observed, 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.

• Brand Name: POSEY BED
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): JT POSEY COMPANY; 5635 peck road; arcadia CA 91006 002
• Manufacturer (Section G): POSEY, S. DE R.L. DE C.V.; ave. ferrocarril no. 16901. bo; colonia rio tijuana, 3ra. etap; tijuana 2266 4; MX 22664
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4629145
• MDR Text Key: 5658021
• Report Number: 2020362-2015-00038
• 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: Other
• Type of Report: Initial
• Report Date: 03/18/2015

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: Health Professional
• Device Model Number: 8070
• Device Catalogue Number: 8070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2015
• Initial Date FDA Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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