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

Model Number 8070

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Customer states that a child was able to fall out of the 8070 bed.Additional details of the incident are unknown right now.We are e-mailing the customer requesting additional information regarding the incident.A sn was provided but did not seem to register in the system.

Manufacturer Narrative

H3 this report is based solely on the information provided by the customer.A request for additional information surrounding the patient fall was attempted but have not received a response from the customer at the time of this report.The customer provided a serial number (b)(6) that calculates to about 15 years old which is beyond the useful life of the canopy.Based on the age of the canopy, repeated use and laundering could potentially damage the unit.Additionally, maintenance and/or cleaning of the unit can also cause damage, as well as abusive handling.Previous investigations and servicing have revealed that these issues are unlikely to have been caused by a manufacturing non-conformity.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.The instructions for use are adequate in providing clear and concise warnings against putting a damaged canopy into use with a patient.The instructions states: warning, never use the posey bed if there is damage to the canopy, access panels or zippers.A failure to heed this warning may result in patient escape or unassisted bed exit, which may lead to serious injury or death from a fall.Always check the canopy and the zippers before leaving the patient unattended to help reduce the risk of a fall or unassisted bed exit.Never leave a patient unattended if the zippers do not close securely, there are holes in the canopy or netting, the foam padding covering the metal frame is damaged or missing, or the frame is damaged.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).H3 other text : product not returned.

Event Description

Supplemental medwatch being sent for additional information.

Manufacturer Narrative

Customer confirmed the product will not be returning for analysis.The customer found through investigation that the netting enclosure was not secured by staff at the time of the incident, and patient did not sustain any injuries.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.The instructions for use are adequate in providing clear and concise warnings against putting a damaged canopy into use with a patient.The instructions states: warning, never use the posey bed if there is damage to the canopy, access panels or zippers.A failure to heed this warning may result in patient escape or unassisted bed exit, which may lead to serious injury or death from a fall.Always check the canopy and the zippers before leaving the patient unattended to help reduce the risk of a fall or unassisted bed exit.Never leave a patient unattended if the zippers do not close securely, there are holes in the canopy or netting, the foam padding covering the metal frame is damaged or missing, or the frame is damaged.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).

• Brand Name: POSEY BED 8070
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 18623366
• MDR Text Key: 334328453
• Report Number: 2182318-2024-00005
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8070
• Device Catalogue Number: 8070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2008
• 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