MAUDE Adverse Event Report: POSEY PRODUCTS LLC POSEY BED 8060; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number 8060

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Evaluation results : evaluation of the returned canopy found an open slider in a patient access area which could allow the unintentional patient escape.In addition, there was a 1/2 inch tear on the front side window.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, it is possible that an excessive amount of force was applied to the pull tab, which could have bent the slider body open.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.Manufacture reference file # (b)(4).

Event Description

Customer reported the canopy has a damaged zipper.The date the issue was discovered is unknown and there was no patient incident or injury reported.

• Brand Name: POSEY BED 8060
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck road; arcadia CA 91006
• Manufacturer (Section G): POSEY S DE RL DE CV; cam. antigua a tecate #16760 i; colonia niños heroes este; tijuana, baja california 22120 ; MX 22120
• Manufacturer Contact: william hincy ; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6861761
• MDR Text Key: 86602023
• Report Number: 2020362-2017-00069
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2017

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
• Device Model Number: 8060
• Device Catalogue Number: 8060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1