MAUDE Adverse Event Report: CARDINAL HEALTH NPWT FACILITY NPWT CATALYST; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 68-1132

Device Problems Device Alarm System (1012); Decrease in Suction (1146)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

Device was released from qa to stock on 03/07/2020.Job router was reviewed without issue, service records were reviewed without issues.Serial number (b)(4) device passed all in process test results.The sample was not returned for investigation; therefore, the root cause for the reported concern cannot be determined.No action will be taken at this time.We will continue to monitor for trends of this issues.

Event Description

Customer reported that the device alarm was not beeping when there was an air leak and it was not holding pressure well.No further information was provided by the customer.No injury was reported.

• Brand Name: NPWT CATALYST
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CARDINAL HEALTH NPWT FACILITY; 8322 eagle palm drive; riverview FL
• Manufacturer (Section G): CARDINAL HEALTH NPWT FACILITY; 8322 eagle palm drive; riverview FL 33578
• Manufacturer Contact: patricia tucker ; 2651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 13657108
• MDR Text Key: 291751314
• Report Number: 1423537-2022-00730
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 10885380153181
• UDI-Public: 10885380153181
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 68-1132
• Device Catalogue Number: 68-1132
• Device Lot Number: 23429
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1