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

Model Number 2874

Device Problem Sharp Edges (4013)

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

Event Date 04/01/2023

Event Type  malfunction  

Event Description

This report summarizes 1 malfunction event, where it was reported the device experienced sharp metal edges.There was no patient involvement.

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.

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 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
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17350153
• MDR Text Key: 319515944
• Report Number: 0001831750-2023-00708
• 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): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 07/01/2023
• Initial Date FDA Received: 07/19/2023
• Supplement Dates Manufacturer Received: 07/01/2023
• Supplement Dates FDA Received: 09/19/2023
• 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