MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ULTRA COMFORT, SE 3 X 30 INTL; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 1703034301

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); No Patient Involvement (2645)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

This mdr is part of the fda voluntary malfunction summary reporting program.Six devices were evaluated in the field but the issue was not confirmed; no defect or malfunction was found.Five devices were not made available for testing by the customer; no cause was established.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 11 malfunction events, where it was reported the mattress slipped off.There was one instance of patient involvement where it was reported the patient fell, but there were no adverse consequences.

• Brand Name: ULTRA COMFORT, SE 3 X 30 INTL
• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 9638782
• MDR Text Key: 176868007
• Report Number: 0001831750-2020-00280
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 11
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2020

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: 1703034301
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/01/2020
• Initial Date FDA Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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