Device product

AC Powered hospital adjustable bed.

Z-2205-2020

May 04, 2020

Class II

Product summary

Firm: Umano Medical, Inc.
Event: Event 85592
Status: Terminated
Classification: Class II
Quantity: 3259 beds
Official record key: device-enforcement:Z-2205-2020

Official wording

Reason: Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.

Code information: Model FL36 Numbers OL360011P or OL360017P

Distribution pattern: Domestic distribution: AR, CA, FL, GA, UT, MS, NY, PA International distribution: Australia, Brasil, Canada and United Kingdom.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.