HONEYWELL HOMMED WIRED SCALE (JUNO) 5002100A2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-01-04 for HONEYWELL HOMMED WIRED SCALE (JUNO) 5002100A2 manufactured by Honeywell Hommed.

Event Text Entries

[19198457] During vital signs acquisition in her home, the pt fell off honeywell hommed scale (juno model 5002100a2, s/n (b)(4)). The pt had been nauseated and had two emesis prior to getting on the scale. The pt indicated that she was weak at the time she fell. The pt was hospitalized following the event. An mri was performed of her back, however, the hospital has not addressed if the mri is related to the fall. The scale was not reported to be defective, however, the facility inquired if we offered a stand or other safeguards for the scale. Honeywell hommed does not offer a stand with the scale but the juno scale is designed with an anti-tipping edge. The juno scale is cabled to the genesis dm monitor (telehealth monitor) which collects the pt's weight and transmits the results via a communication module to a central viewing station in the user's facility for retrospective review. The user instructions (p4510en. 07, 02/16/2012) indicate the scale is to be positioned on a hard, non-carpeted area and if the area is carpeted the scale bottom should clear the carpet so that when the pt stands on the scale the weight is distributed to the scale's load cells. The manual also indicates that the pt should be properly positioned in the center of the scale and remain motionless during scale use. The manual recommends for pts who are unable to remain motionless without assistance (a wall, chair, helper, etc. ) throughout the time it takes for the weight to be measured should not use the scale. The pt manual (p4530en. 03, 03/01/2012) indicates to place feet toward the center of the scale not on or near the edge and to stand still until the monitor tells you to step off the scale. Upon f/u with the user facility, they indicated they had filled out an incident form and as a precaution they are not installing scales for any pt that seems unsteady on their feet. They removed the scale from this particular pt's home and they indicated they are looking at bars for pts that are unsteady but need to provide weight readings.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3004183721-2013-00001
• MDR Report Key: 2920140
• Report Source: 06
• Date Received: 2013-01-04
• Date of Report: 2012-12-07
• Date of Event: 2012-10-04
• Date Mfgr Received: 2012-12-07
• Device Manufacturer Date: 2011-03-27
• Date Added to Maude: 2013-01-18
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: CLAUDIA JACKSON
• Manufacturer Street: 3400 INTERTECH DR. SUITE 200
• Manufacturer City: BROOKFIELD WI 53045
• Manufacturer Country: US
• Manufacturer Postal: 53045
• Manufacturer Phone: 2622525838
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HONEYWELL HOMMED WIRED SCALE (JUNO)
• Generic Name: SCALE, STAND-ON, PT
• Product Code: FRI
• Date Received: 2013-01-04
• Model Number: 5002100A2
• Catalog Number: 5002100A2
• Device Expiration Date: 2017-03-27
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HONEYWELL HOMMED
• Manufacturer Address: BROOKFIELD WI US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2013-01-04