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	Defective Alarm (1014)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device doesn¿t alarm when blocked and rattle inside unit was noticed.No case involved.
Additional Manufacturer Narrative
Additional information received by the customer has identified that this event has been already reported under 8043484-2020-01114.The new information confirms that this is a duplicate complaint, therefore, if further details are provided in future confirming the opposite, our files will be updated accordingly and a further report will be submitted outlining both events details and our investigations performed.

• 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: 10224723
• Report Number: 8043484-2020-01338
• Device Sequence Number: 2095274
• Product Code: OMP
• UDI-Device Identifier: 00040565126470
• UDI-Public: 00040565126470
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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: 06/10/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1