MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS EZ MAX HOSPITAL; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	66801309
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing the renasys unit had an intermittent start.No case involved.During functional evaluation it was confirmed that the device had no suction.

• Brand Name: RENASYS EZ MAX HOSPITAL
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11318748
• Report Number: 8043484-2021-00292
• Device Sequence Number: 14264770
• Product Code: OMP
• UDI-Device Identifier: 00040565126470
• UDI-Public: 00040565126470
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2021

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: Health Professional
• Device Model Number: 66801309
• Device Catalogue Number: 66801309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 02/11/2021
• Patient Sequence Number: 1