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

Model Number 8070

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the product is scheduled to be returned but has not been received in by manufacturer at the time of this report.Therefore, this report is based solely on the information provided by the customer.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The 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 fda report 1900150000-2022-8010 / manufacturer reference file (b)(4).Product not yet returned.

Event Description

Customer is filing a medwatch complaint for a posey enclosure bed.Customer states that the s/n is (b)(4) but this is not a valid s/n for a posey bed.(b)(6) rn put a complaint in for (b)(6).He has a contact # of (b)(6) or by e-mail at (b)(6).Secondary contact person is (b)(6).Customer states "the patient was lying against the side wall of the enclosure bed.The zipper at the bottom of the bed (enclosed mattress compartment) separated.Allowing the patient to slide out onto the floor".

Event Description

Supplemental medwatch being sent for additional information.

Manufacturer Narrative

H3 evaluation of the retuned canopy was received with the right side window and mattress envelope zippers opened.When the right side window and mattress envelope zippers were closed, both zippers worked properly.No abnormalities have been observed.Evaluation found that the device met specifications and passed all functional testing.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The 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 fda report (b)(4) / manufacturer reference file (b)(4).

• Brand Name: POSEY BED 8070
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise dr; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 16287517
• MDR Text Key: 308836264
• Report Number: 2182318-2023-00002
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

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 Model Number: 8070
• Device Catalogue Number: 8070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 02/02/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2020
• 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
• Patient Sex: Male