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U.S. Department of Health and Human Services

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

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TIDI PRODUCTS LLC POSEY BED 8070; PATIENT BED WITH CANOPY/RESTRAINTS Back to Search Results
Model Number 8070
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Customer returning 8070 canopy for repair.Lot# 2174t027 has unspecified location zipper damages.Customer has requested a warranty evaluation of the zipper.Customer states the zipper was damaged out of the packaging.
 
Manufacturer Narrative
H3 evaluation of the canopy found a zipper that does not engage correctly in a patient access area.A zipper that does not engage correctly may allow the zipper to be initially closed.A patient can later open the zipper by applying pressure to the zipper at the location of the misaligned zipper elements (teeth).In this case, there was no impact or consequence to the patient and the canopy was returned for servicing when the zipper issue was identified.Based on the lot number of the canopy, it has been in use for 20 months with this being the first time returned for service.Although it cannot be confirmed, it is possible that routine wear-and-tear from repeated use contributed to the zipper damage.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.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.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).
 
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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 Key19035845
MDR Text Key339287422
Report Number2182318-2024-00056
Device Sequence Number1
Product Code OYS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/08/2024
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 Number8070
Device Catalogue Number8070
Device Lot Number2174T027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/01/2024
Initial Date FDA Received04/03/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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