MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOTOUR, 84 INCH,STD, END406; MATTRESS, FLOATATION THERAPY, NON-POWERED

Model Number	2872
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 1 malfunction event, where it was reported the device was too heavy/difficult to move.There was no patient involvement.
Additional Manufacturer Narrative
This supplemental is being filed to correct the common device name and product code in section b.Through communication/interviews with the user facility, the issue was not confirmed; no defect or malfunction was found.
Event or Problem Description
This report summarizes 1 malfunction event, where it was reported the device was too heavy/difficult to move.There was no patient involvement.

• Brand Name: ISOTOUR, 84 INCH,STD, END406
• Common Device Name: MATTRESS, FLOATATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 12234214
• Report Number: 0001831750-2021-01082
• Device Sequence Number: 3245114
• Product Code: IKY
• UDI-Device Identifier: 07613327424638
• UDI-Public: 07613327424638
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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
• Operator of Device: No Information
• Device Model Number: 2872
• Device Catalogue Number: 2872000012
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1