MAUDE Adverse Event Report: INTEGRATED MEASUREMENT SYSTEMS DIGITAL SCALE; LIFT SCALE

Model Number 59011A

Device Problems Material Separation (1562); Component Missing (2306)

Patient Problem Fall (1848)

Event Date 08/24/2017

Event Type  malfunction  

Event Description

It was reported to the manufacturer by the end user, per the end user "the resident was being raised up out of their wheel chair and weighed using the hoyer presence lift scale.When the cradle king pin came detached from the scale and the resident dropped back down into her wheelchair seat." the patient complained of pain in the right hip.A mobile x-ray unit was brought to the facility to x-ray the hip and the results were negative.Upon speaking to the facility, it was communicated that the king bolt unscrewed from the bottom of the scale and fell with the resident.The retaining pin, that secured the king bolt to the scale, was missing at the time of the incident.Complaint#(b)(4) and ra#(b)(4) were entered into our system to have the lift and scale returned to joerns for investigation.As of this writing, the lift and scale has not been returned.

• Brand Name: DIGITAL SCALE
• Type of Device: LIFT SCALE
• Manufacturer (Section D): INTEGRATED MEASUREMENT SYSTEMS; 1104 heinz drive, unit b; east dundee IL 60118
• Manufacturer (Section G): INTEGRATED MEASUREMENT SYSTEMS; 1104 heinz drive, unit b; east dundee IL 60118
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 6831951
• MDR Text Key: 84257063
• Report Number: 3009402404-2017-00040
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 59011A
• Device Catalogue Number: 59011A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 81