MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. PRO II NPWT PUMP; NEGATIVE PRESSURE WOUND THERAPY PUMP (OMP)

Model Number	NP-2000
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received on 1/30/2024 reporting "i have had your nwt wound vac since (b)(6) 2024.We have not been able to keep a dressing on for more than five hours.That is with three different experienced registered nurses and one doctor attempting to apply it.Due to these problems your machine has caused a skin breakdown." this investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Event or Problem Description
I have had your nwt wound vac since (b)(6) 2024.We have not been able to keep a dressing on for more than 5 hours with three different experienced registered nurses and one doctor attempting to apply it.Due to these problems your machine has caused skin breakdown.
Additional Manufacturer Narrative
A complaint was received on 1/30/2024 reporting "i have had your nwt wound vac since (b)(6) 2024.We have not been able to keep a dressing on for more than five hours.That is with three different experienced registered nurses and one doctor attempting to apply it.Due to these problems your machine has caused a skin breakdown." the complaint sample was received and diagnostics testing was performed on the device.Testing indicates that the complaint sample was working properly.The units firmware was updated to current revision and the unit was returned to osf home care services.The potential root cause was determined to be an application error regarding the dressing.The customer stated that the device alarmed when used which is a risk control for poor dressing application.Deroyal provides a user manual and trouble shooting card with the unit upon purchase to help the end user understand how to operate and function the device.Deroyal will continue to monitor through the complaint handling system.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: PRO II NPWT PUMP
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY PUMP (OMP)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1703 hwy 33 south; new tazewell TN 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 hwy 33 south; new tazewell TN 37825
• Manufacturer Contact: rose earl ; 200 debusk lane; powell, TN 37849 ; 8653621051
• MDR Report Key: 18797717
• Report Number: 1060680-2024-00001
• Device Sequence Number: 7162712
• Product Code: OMP
• UDI-Device Identifier: 00749756781053
• UDI-Public: 00749756781053
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: NP-2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown