MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUSHION ASSY SPR-PLUS BOX OF 6; BED, FLOTATION THERAPY, POWERED

Catalog Number	2790100000
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the spr overlay is leaking.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: CUSHION ASSY SPR-PLUS BOX OF 6
• Common Device Name: BED, FLOTATION THERAPY, 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 19560540
• Report Number: 0001831750-2024-00716
• Device Sequence Number: 4811510
• Product Code: IOQ
• UDI-Device Identifier: 57613327175047
• UDI-Public: 57613327175047
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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 Catalogue Number: 2790100000
• Device Lot Number: 489578
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown