MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISO TOUR PUMP DOM CAN; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number	2874
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 1 malfunction event, where it was reported the device experienced sharp metal edges.There was no patient involvement.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was functionally/visually inspected in the field.The device was repaired and returned to use.There was no remedial action taken.This device is not labeled for single use.
Additional Manufacturer Narrative
The device that was evaluated was further determined the device experienced sharp plastic edges, which is not reportable.Section h codes have been updated.Because of this, the number of reported events has been changed from 1 to 0.
Event or Problem Description
This report summarizes 0 malfunction event, where it was reported the device experienced sharp metal edges.There was no patient involvement.

• Brand Name: ISO TOUR PUMP DOM CAN
• Common Device Name: 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17350153
• Report Number: 0001831750-2023-00708
• Device Sequence Number: 17465373
• Product Code: IKY
• UDI-Device Identifier: 07613327471427
• UDI-Public: 07613327471427
• 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): 09/19/2023

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 Model Number: 2874
• Device Catalogue Number: 2874000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2023
• Supplement Date Received by Manufacturer: 07/01/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown