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); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that one renasys ez max hospital is burnt, the alarm does not work, and the battery cannot charge.As this was noticed upon service and repair activities, there was not patient involvement.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, has been returned and evaluated.A visual inspection reported no defects.The functional evaluation confirmed the device failed to charge, establishing a relationship between the reported events.The root cause was identified as a defective pcb and a depleted battery.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• 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: 12450689
• Report Number: 8043484-2021-01766
• Device Sequence Number: 4381612
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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: 10/04/2021
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1