MAUDE Adverse Event Report: KCI USA, INC. PREVENA¿; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	PRE1001US
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The battery pack on the kci machine failed so we opened a second device and that one worked.The first package was sent back for credit.

• Brand Name: PREVENA¿
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KCI USA, INC.; 12930 ih 10 west; san antonio TX 78249
• MDR Report Key: 7243546
• Report Number: 7243546
• Device Sequence Number: 917808
• Product Code: OMP
• UDI-Device Identifier: 00849554000117
• UDI-Public: (01)00849554000117(17)200131(10)3704878
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2018
• Report Date (Section F): 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Unknown
• Device Expiration Date: 01/31/2020
• Device Model Number: PRE1001US
• Device Lot Number: 3704878
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2018
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/29/2018