MAUDE Adverse Event Report: CIRPRO DE DELICIAS S.A. DE C.V. NPWT PRO NPWT THERAPY DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	6708888
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Customer reported the device was not suctioning and there was a failure to alarm.There was no patient injury, as the device was immediately removed from patient.
Additional Manufacturer Narrative
Supplemental report is being filed following the submission of the initial mdr report since the investigation has been completed.Based on the lot number provided for product 6708888, we reviewed the device history record (dhr).There were no reports of any deviation or non-conformance investigations (nci) generated for the lot number.The sample was never received for evaluation, therefore the root cause cannot be determined.We will continue to monitor this failure mode for this product.

• Brand Name: NPWT PRO NPWT THERAPY DEVICE
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CIRPRO DE DELICIAS S.A. DE C.V.; las virgenes industrial park,; delicias, chihuahua 33019 ; MX 33019
• Manufacturer (Section G): CIRPRO DE DELICIAS S.A. DE C.V.; las virgenes industrial park,; delicias, chihuahua 33019 ; MX 33019
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085
• MDR Report Key: 14107033
• Report Number: 1423537-2022-00745
• Device Sequence Number: 12002172
• Product Code: OMP
• UDI-Device Identifier: 10885380103520
• UDI-Public: 10885380103520
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2022

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: 6708888
• Device Catalogue Number: 6708888
• Device Lot Number: D012100138
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown