MAUDE Adverse Event Report: KCI USA, INC. 3M¿ VAC®; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	CAPULTDEV01/US
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Wound vacuum attached to patient, shows that it is running- however, assessment of the wound clearly indicates that there is no suction on the sponge dressing.Troubleshooting attempted to no avail.Screen shows a total of 44:56 of continuous vacuum therapy, but evident not working correctly.System error on history reads- (b)(4).

• Brand Name: 3M¿ VAC®
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KCI USA, INC.; 6203 farinon dr; san antonio TX 78249
• MDR Report Key: 16814974
• Report Number: 16814974
• Device Sequence Number: 17523507
• Product Code: OMP
• UDI-Device Identifier: 00849554008366
• UDI-Public: (01)00849554008366
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/03/2023
• Report Date (Section F): 04/03/2023

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: CAPULTDEV01/US
• Device Catalogue Number: CAPULTDEV01/US
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2023
• 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
• Date Report Sent to FDA: 04/03/2023