MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO AIR PLUS PUMP; BED, FLOTATION THERAPY, POWERED

Model Number	2863-000-000
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device had accessible ac current.No adverse consequences related to the event were reported.

• Brand Name: AIR PLUS PUMP
• Common Device Name: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 11322352
• Report Number: 0001831750-2021-00601
• Device Sequence Number: 14273624
• Product Code: IOQ
• UDI-Device Identifier: 07613327499735
• UDI-Public: 07613327499735
• 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): 02/12/2021

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: 2863-000-000
• Device Catalogue Number: 2863000000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1