MAUDE Adverse Event Report: MEDELA AG PUMP THOPAZ; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	0790000
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medela ag already requested the affected product back for an investigation.The product has not yet been received by medela ag and the investigation has not yet started.
Event or Problem Description
Medela ag (switzerland) was informed that the thopaz tubing was disconnected at the connecting piece.Tubing disconnected spontaneously, without pulling.Health professionals were present when the tube came loose.The tubing was reconnected immediately and was fixed with a tube clamp.The patient was not injured, but such an incident could potentially lead to a pneumothorax according to the hospital.

• Brand Name: PUMP THOPAZ
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer Contact: tom cuzman ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 17405505
• Report Number: 3002807523-2023-00012
• Device Sequence Number: 14942895
• Product Code: OMP
• UDI-Device Identifier: 07612367014205
• UDI-Public: 7612367014205
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K130210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: 0790000
• Device Catalogue Number: 0790000
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/20/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 07/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown