MAUDE Adverse Event Report: POSEY PRODUCTS, LLC POSEY BED 8070; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number 8070

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The canopy was returned and evaluated, confirming canopy damages.Evaluation of the canopy found 30" of frayed/ripped nylon material in the right side patient access area.The evaluation of the canopy also found damage to the left side of the zipper canopy, two zipper elements damaged\missing from the mattress zipper and a pull tab was missing from a patient access zipper.Since the damaged zippers would render the zippers unusable, it is most likely the patient exited the bed through the frayed/ripped material on the opposite side of the canopy.In this case, there was no impact or consequence to the patient.However, there is the potential for patient injury if this malfunction were to reoccur.Although it cannot be confirmed, it is possible that either abnormal use or routine wear-and-tear from repeated use contributed these damages.A historical review of reported events did not reveal any developing trends.This bed was manufactured in 2017 and has exceeded its 3 year useful life.Posey beds are multi-use, serviceable items with a 3 year useful life.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 be put into use with a patient and should be returned to posey for servicing.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.Therefore, no corrective or preventive actions are necessary.As part of a monthly review, trends and excursions above control limits will be assessed, documented and acted upon as warranted.All service events are reviewed by management on a monthly basis.Manufacturer reference file#2021-00192.

Event Description

Customer called and verified via email a canopy that has broken zippers.They confirmed the patient was able to open the canopy up.No injuries sustained.

• Brand Name: POSEY BED 8070
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): POSEY PRODUCTS, LLC; 2350 lindsay privado drive; ontario CA 91761
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 11560996
• MDR Text Key: 250960739
• Report Number: 2020362-2021-00013
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2021

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: No Information
• Device Model Number: 8070
• Device Catalogue Number: 8070
• Device Lot Number: 2017092204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• 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