POSEY BED 8070

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-01-22 for POSEY BED 8070 manufactured by Posey Products Llc.

Event Text Entries

[133839284] Evaluation of the canopy found one element missing on both the right side panel and right side window. Additionally, two inches unraveling on the left side panel was also found. If one zipper element is missing in a patient accessible area, it can allow for the zipper to later be opened by separating the zipper at the location of the missing element. The user manual advised caregivers to apply direct pressure along the entire length of the zipper to reveal the breach of an unsecured area. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[133839305] Customer reported the pull tab is missing from the zipper on the right side panel. The date the issue was discovered is unknown and no patient incident or injury was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020362-2019-00017
MDR Report Key8269502
Report SourceDISTRIBUTOR
Date Received2019-01-22
Date of Report2019-01-04
Date Mfgr Received2019-01-04
Device Manufacturer Date2014-10-30
Date Added to Maude2019-01-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactWILLIAM HINCY
Manufacturer Street5635 PECK ROAD
Manufacturer CityARCADIA CA 91006
Manufacturer CountryUS
Manufacturer Postal91006
Manufacturer Phone6264433143
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOSEY BED 8070
Generic NamePATIENT BED WITH CANOPY/RESTRAINTS
Product CodeOYS
Date Received2019-01-22
Returned To Mfg2018-11-27
Model Number8070
Catalog Number8070
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPOSEY PRODUCTS LLC
Manufacturer Address5635 PECK ROAD ARCADIA 91006 US 91006


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-22

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