MAUDE Adverse Event Report: PERFUSION SYSTEMS ACT PLUS INSTRUMENT; TIMER, CLOT, AUTOMATED

Model Number ACT200

Device Problems Electrical /Electronic Property Problem (1198); Smoking (1585)

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

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the reported wrong data and burning smell issue were verified during service.The field service technician observed that the power supply board needed replacement.The issues were resolved by replacing the power supply board.Post-repair testing was performed per specifications.Conclusion: after investigation the complaint is confirmed for the act plus instrument¿s reported wrong data and burning smell issue.The issue was verified during service when the technician observed power board needs replacement.The issue was resolved by replacing the power supply board.Trends for issues with this device are monitored.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use this act plus instrument had a wrong data issue and a burning smell.The customer stated that the values were poor.Use of the instrument was unspecified.There were no adverse patient effects as a result of this issue.

• Brand Name: ACT PLUS INSTRUMENT
• Type of Device: TIMER, CLOT, AUTOMATED
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13869139
• MDR Text Key: 288517879
• Report Number: 2184009-2022-00044
• Device Sequence Number: 1
• Product Code: GKN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K940426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 03/23/2022

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
• Device Operator: Health Professional
• Device Model Number: ACT200
• Device Catalogue Number: ACT200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1