MAUDE Adverse Event Report: J.T. POSEY POSEY BED 8070; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number 8070

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned bed confirmed that one tooth from the right side panel was missing in addition to a 1 inch tear on the left side netting.All the issues listed were repaired and returned back to the customer for use.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 one zipper element is missing 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.If there are more than one consecutive zipper elements are missing it will not allow the zipper to be closed and will render the bed unusable.In order for a missing zipper element to potentially contribute to patient egress, the following must occur: the missing zipper element is not noticed, 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 these issues 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 it cannot be confirmed, it is possible that routine wear-and-tear from repeated use contributed to the missing zipper element.Of note, the canopy was 13 months old since its last service.Service issues are trended and reviewed by management on a monthly basis.As part of this monthly review, spikes, 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.Manufacturer reference file: (b)(4).

Event Description

Customer reported the slider and zipper teeth were damaged to the zipper located at the foot access panel.

• Brand Name: POSEY BED 8070
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): J.T. POSEY; 5635 peck rd; arcadia CA 91006
• Manufacturer (Section G): POSEY, S. DE R.L. DE C.V.; ave ferrocarrill no. 16901. bo; colonial rio tijuana,3ra. etap; tijuana, mexico 22664 ; MX 22664
• Manufacturer Contact: william hincy ; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6081134
• MDR Text Key: 59288870
• Report Number: 2020362-2016-00047
• 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: 10/04/2016

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: Other Caregivers
• Device Model Number: 8070
• Device Catalogue Number: 8070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2014
• 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