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

Model Number 8060

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Inspection found a zipper element is missing, which can allow for the unintentional opening of the canopy window.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.It is unknown whether this malfunction was discovered at set-up or during patient use.This device was manufactured and sold in 2016, there is no evidence to suggest a manufacturing non-conformity at this time.No injuries to the patient or caregiver were associated with this event.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.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 be put into use with a patient and should be returned to posey for servicing.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.Manufacturer reference file #: (b)(4).

Event Description

On hold for denisse 09/01 the customer reported via email that the zipper teeth of a zipper is not staying shut on the left side of the canopy.

• Brand Name: POSEY BED 8060
• Type of Device: PATIENT BED WITH CANOPY\RESTRAINTS
• Manufacturer (Section D): TIDI PRODUCTS LLC; 2350 lindsay privado drive; unit a; ontario, ca
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, wi ; 7514300400
• MDR Report Key: 10477144
• MDR Text Key: 205498276
• Report Number: 2020362-2020-00111
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2020

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: 8060
• Device Catalogue Number: 8060
• Device Lot Number: 2016011204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2016
• 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