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

Model Number 2872

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  malfunction  

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 Description

This report summarizes 1 malfunction event, where it was reported the device was too heavy/difficult to move.There was no patient involvement.

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 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
• Type of Device: MATTRESS, FLOATATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 12234214
• MDR Text Key: 263873240
• Report Number: 0001831750-2021-01082
• Device Sequence Number: 1
• Product Code: IKY
• UDI-Device Identifier: 07613327424638
• UDI-Public: 07613327424638
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 2872
• Device Catalogue Number: 2872000012
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1