MAUDE Adverse Event Report: CUSTOM SCALE SOLUTIONS INC DIGITAL SCALE; DIGITAL SCALE FOR PATIENT LIFT,

Model Number 59011A

Device Problem Material Separation (1562)

Patient Problems Fall (1848); Injury (2348)

Event Date 10/27/2017

Event Type  Injury  

Manufacturer Narrative

The scale was attached to the hpl402 lift.See below for product information: brand name: hoyer hpl402.Common name: electric patient lift, product code: fsa.Mfr name: (b)(4).Model#: hpl402, catalog#: hpl402, serial# (b)(4).Operator of device: health professional.

Event Description

It was reported to the manufacturer by the end user, per the end user, "scale king pin retaining screw keeps coming out and the cradle separates from the scale dropping the resident.The cradle fell onto the patient's head.Resident was sent to the er for dizziness and head swelling." 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.

• Brand Name: DIGITAL SCALE
• Type of Device: DIGITAL SCALE FOR PATIENT LIFT,
• Manufacturer (Section D): CUSTOM SCALE SOLUTIONS INC; 570 rock road dr ste h; east dundee IL 60118
• Manufacturer (Section G): CUSTOM SCALE SOLUTIONS INC; 570 rock road dr ste h; east dundee IL 60118
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 7118620
• MDR Text Key: 94923622
• Report Number: 3009402404-2017-00061
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/04/2017
• 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 Outcome(s): Hospitalization
• Patient Weight: 76