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

Model Number 8070

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Product is scheduled to be returned but have not been received at the time of this report.Therefore, this report is based solely on the information provided by the customer.There was no reported injury to the patient or caregiver as a result of this event.A historical review of complaints received from 2018 thru 2021 was conducted with 5 similar complaints received during this time period.No injuries to the patient or caregiver was associated with any of these events.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 at this time.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.(b)(4).

Event Description

08-24-2021 (b)(6) the customer contacted us via e-mail.The customer states "per the below, agiliti has received notification that tix 2359 ((b)(4)) and tqw 0340 ((b)(4)) - enclosure bed canopy and frame were reported to have been involved in an equipment incident.There was no injury to the patient.Agiliti will perform testing of these units.This is just a fyi, and nothing further is needed.Nurse (b)(6) reported on (b)(6) 2021 that an incident occured with a posey bed and a patient the night before on (b)(6) 2021.A posey bed was ordered for a patient on (b)(6) 2021.The patient was in the posey bed and opened the zipper from the inside the bed and fell out.The nurse reported that there was no injury suffered in the incident.Our agiliti a360 on site evening coord (b)(6) picked up the posey enclosure bed on the evening of (b)(6) 2021 and discovered that the zipper threads had come apart.Not realizing the bed was part of an incident report she attempted to fix the canopy by trying an on-site realigning of the zipper threads.In the process of attempting this she broke the zipper.No other information is available with this complaint.

• Brand Name: POSEY BED
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise dr; neenah WI 54956
• MDR Report Key: 12514999
• MDR Text Key: 282294817
• Report Number: 2020362-2021-00054
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• PMA/PMN Number: K113357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 08/24/2021

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: 5605
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1