MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MATTRESS/ ALT. PRESSURE

Catalog Number MDT24DSRE

Device Problem Deflation Problem (1149)

Patient Problem Fracture, Arm (2351)

Event Date 05/15/2015

Event Type  Injury  

Event Description

One of the side bolsters on the mattress deflated and the end user fell.

Manufacturer Narrative

It was reported that one fo the side bolsters deflated and the end user fell out of bed resulting in a left arm fracture.The sample was returned and evaluated.The mattress was in used condition and out of warranty.The tubing between tow of the bolster sections had become separated, resulting in the deflation of the bolster.The root cause has been determined to be an inappropriately maintained device.The ari cells, including the side bolsters can e replaced by the user and did show signs of wear.The device is a pressure relieving mattress and as indicated in the owner's manual.The side bolster is not intended to prevent a patient from falling.

• Brand Name: MATTRESS/ ALT. PRESSURE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4872076
• MDR Text Key: 6048042
• Report Number: 1417592-2015-00052
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MDT24DSRE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2015
• Initial Date FDA Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• 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): Other
• Patient Age: 95 YR
• Patient Weight: 75