POSEY BED 8070

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-09 for POSEY BED 8070 manufactured by Posey Products Llc.

Event Text Entries

[102215117] Evaluation of the returned canopy found one element missing on the right window drainage port and one element missing on the molding zipper a patient access area. If one zipper element is missing or pulled apart on a patient accessible zipper it would allow the zipper to be initially closed. A patient can later open the zipper by separating the zipper at the location of the missing element. 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. 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


[102215118] Customer reported the zipper teeth are missing from the right side panel of the canopy. The date the issue was discovered is unknown. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020362-2018-00020
MDR Report Key7327795
Date Received2018-03-09
Date of Report2018-02-27
Date Mfgr Received2018-02-19
Device Manufacturer Date2014-05-02
Date Added to Maude2018-03-09
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 StreetPOSEY PRODUCTS LLC 5635 PECK ROAD
Manufacturer CityARCADIA CA 91006
Manufacturer CountryUS
Manufacturer Postal91006
Manufacturer Phone6264433143
Manufacturer G1POSEY S DE RL DE CV
Manufacturer StreetCAM. ANTIGUA A TECATE #16760 I COLONIA NI
Manufacturer CityTIJUANA, BAJA CALIFORNIA 22120
Manufacturer CountryMX
Manufacturer Postal Code22120
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NamePOSEY BED 8070
Generic NamePATIENT BED WITH CANOPY/RESTRAINTS
Product CodeOYS
Date Received2018-03-09
Returned To Mfg2018-02-19
Model Number8070
Catalog Number8070
Lot NumberNA
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPOSEY PRODUCTS LLC
Manufacturer Address5635 PECK ROAD ARCADIA CA 91006 US 91006


Patients

Patient NumberTreatmentOutcomeDate
10 2018-03-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.