MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; SLEEVE, LIMB, COMPRESSIBLE

Model Number MDS600INT

Device Problems Break (1069); Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2020

Event Type  malfunction  

Event Description

Issue involving usability of the device when the battery is critically low or the device is used without a battery and external power (ac power) only.The device takes a considerably long time to power on.The power button needs to be held down for upwards of 10 seconds or longer causing the clinical staff to believe the device is broken.This presents a human factors issue.

• Brand Name: MEDLINE
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 10599482
• MDR Text Key: 208972478
• Report Number: 10599482
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDS600INT
• Device Catalogue Number: MDS600INT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2020
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1