MAUDE Adverse Event Report: EMG SUCTION APPARATUS, PATIENT CARE; 870.5050

Model Number IRC1135

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Very low output, only reaches 30 centimeters of mercury, per dealer.

• Brand Name: SUCTION APPARATUS, PATIENT CARE
• Type of Device: 870.5050
• Manufacturer (Section D): EMG; zhongshan ; CH
• MDR Report Key: 3996844
• MDR Text Key: 15178465
• Report Number: 1531186-2014-03087
• Device Sequence Number: 1
• Product Code: DWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/07/2014,07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC1135
• 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: 08/07/2014
• Distributor Facility Aware Date: 07/09/2014
• Device Age: 1 YR
• Date Report to Manufacturer: 08/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other