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 Patient Involvement (2645)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during service evaluation the device was not able to generate alarms under expected alarm conditions.No case involved.
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 generate alarms under expected alarm conditions and the root cause identified as a defective mainboard.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history found other related 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 HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10749533
• Report Number: 8043484-2020-03298
• Device Sequence Number: 14190420
• Product Code: OMP
• UDI-Device Identifier: 00040565126470
• UDI-Public: 00040565126470
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 04/09/2021

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
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1