MAUDE Adverse Event Report: EMG TECHNOLOGY CO. LTD ENVOY AER COMPRESSOR 230V UK 9153633106; COMPRESSOR, AIR, PORTABLE

Model Number IRC1740

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The end user states, she has to hold down the power button to get the unit to work.

• Brand Name: ENVOY AER COMPRESSOR 230V UK 9153633106
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): EMG TECHNOLOGY CO. LTD; no. 58, 35 rd taichung; industrial park, shituen chiu; taichung ; TW
• MDR Report Key: 4324323
• MDR Text Key: 5129325
• Report Number: 1531186-2014-06175
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/10/2014,11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC1740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/10/2014
• Distributor Facility Aware Date: 11/20/2014
• Device Age: 4 YR
• Date Report to Manufacturer: 12/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other