inforMED
MalfunctionFSA

UNIVERSAL SCALE

Received Jan 15, 2018 · Event occurred Nov 20, 2017

Report 1317256-2017-00001 · MDR key 7192662

Device

Generic name

Patient Lift Scale

Manufacturer

Sr Instruments Inc

Model number

HOY-SCALE-LP

Catalog number

HOY-SCALE-LP

Product problems

  • Device Maintenance Issue
  • Device Maintenance Issue

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE FOLLOWING INFORMATION IS COPIED FROM THE 30 DAY REPORT RECEIVED FROM JOERNS: ADDITIONAL SUSPECT MEDICAL DEVICE: BRAND NAME: HOYER HPL700. MODEL# & CATALOG#: HPL700. SERIAL#: (B)(4). MANUFACTURER: (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES. OPERATOR OF DEVICE: HEALTH PROFESSIONAL. AS OF 1/14/2018 NO ADDITIONAL INFORMATION FROM JOERNS HAS BEEN RECEIVED.

Description of Event or Problem

WAS NOTIFIED FROM JOERNS (B)(4) 2017 THAT A PRODUCT PROBLEM HAD OCCURRED CONTENT COPIED BELOW: "IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, "THE CRADLE (KING PIN) UN-SCREWED AND DROPPED THE PATIENT AND CRADLE." UPON SPEAKING TO THE FACILITY, THEY STATED THAT "THE PATIENT WAS BEING TRANSFERRED FROM BED TO WHEELCHAIR. THE SCREWS ON THE BOTTOM OF THE SCALE CAME UN-DONE. THE RESIDENT DID NOT FALL, BUT WAS LOWERED BACK ONTO THE BED." COMPLAINT# (B)(4) WERE ENTERED INTO OUR SYSTEM TO HAVE THE LIFT RETURNED TO JOERNS FOR INVESTIGATION. AS OF THIS WRITING, THE LIFT HAS NOT BEEN RETURNED."