SCALE-TRONIX 4002 INFANT SCALE 42110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-18 for SCALE-TRONIX 4002 INFANT SCALE 42110 manufactured by Scale-tronix, Inc..

Event Text Entries

[4623855] While doing preventive maintenance(pm) on the ohmeda 4400 open infant warmer and checking the in-bed scale-tronix 4002 scale, the biomed tech noticed a potential safety hazard. The scale underneath each mattress has two pieces, the top piece and the actual scale. They clip together with two silver spring-loaded clips/pins. During the pm it was found that the two pieces of the scale would not completely clip together and as a result the top piece of the scale was slipping off the scale. The hole for the spring clip was worn and an edge developed so the clip was not engaging properly. The mattress sits on the upper piece of the scale. Under ideal circumstances if the bed "wing" was left down and if these two scale pieces are not clipped together properly the baby, mattress, and top section of scale have the potential to slide out and fall. The problem seems to come from normal wear and tear on these scales. We are reporting this as something to watch for during maintenance. We have advised our nursing staff of the potential risk with this issue. In the meantime we are inspecting all of our beds for this problem.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3956937
• MDR Report Key: 3956937
• Date Received: 2014-07-18
• Date of Report: 2014-07-18
• Date of Event: 2014-07-11
• Report Date: 2014-07-18
• Date Reported to FDA: 2014-07-18
• Date Reported to Mfgr: 2014-07-25
• Date Added to Maude: 2014-07-25
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• 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: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SCALE-TRONIX 4002 INFANT SCALE
• Generic Name: SCALE, PATIENT
• Product Code: FRW
• Date Received: 2014-07-18
• Model Number: 4002
• Catalog Number: 42110
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SCALE-TRONIX, INC.
• Manufacturer Address: 288 CARLTON DR CAROL STREAM IL 60188 US 60188

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-07-18