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 Codes	Defective Alarm (1014); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the inspection of new devices it was detected the renasys ez pump doesn´t activate the canister full alarm function.It was detected the pressure gauge hose was not positioned properly and it is very short for the distance to the nearest hose coupler.No procedure involved since it was a out of box failure.
Additional Manufacturer Narrative
Additional information was received that identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• 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 east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11612276
• Report Number: 8043484-2021-00746
• Device Sequence Number: 17064808
• Product Code: OMP
• UDI-Device Identifier: 00040565126470
• UDI-Public: 00040565126470
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K132446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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?: Yes
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1