MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ULTRA COMFORT, SE 4 X 26; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 1704034600

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2018

Event Type  malfunction  

Event Description

It was reported that the mattress was sliding off the stretcher during patient transfers from one stretcher to another.This almost caused the patients to fall.However, no patient fell in regards to this event.

• Brand Name: ULTRA COMFORT, SE 4 X 26
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7899583
• MDR Text Key: 121719640
• Report Number: 0001831750-2018-01053
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1704034600
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2018
• 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