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	Device Alarm System (1012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during service and repair, the renasys ez max could not start up correctly, contains critical errors and cannot operate on ac or battery power nor recharge the battery, because the battery does not keep the charge, also the device fail to alarm and is noisy and vibe; no case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
The device intended for use in treatment was returned for evaluation and we have established a relationship between the device and the reported event.A visual inspection found no defects.The functional evaluation found that the device failed to charge; could not start-up correctly free from critical errors, could not operate on ac or battery power, could not generate and control negative pressure, could not generate alarms under the expected alarm conditions and the root cause identified as a defective pump and a defective battery.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances/related events of the reported events.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

• 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: 10623490
• Report Number: 8043484-2020-03111
• Device Sequence Number: 2536583
• Product Code: OMP
• UDI-Device Identifier: 00040565126470
• UDI-Public: 00040565126470
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K142979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: Other
• Device Model Number: 66801309
• Device Catalogue Number: 66801309
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1