MAUDE Adverse Event Report: MEDELA AG THOPAZ+ PUMP W/ AC ADAPTOR (1; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	0791000
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medela ag was informed that the affected device stopped working because the battery was discharged without any indication.The patient's condition then deteriorated until the nurse realized that the pump has stopped working.
Additional Manufacturer Narrative
Medela ag immediately got in contact with the respective hospital in order to collect further relevant information to the case.Additionally, the device was asked to be send back to medela ag for a technical analysis.
Additional Manufacturer Narrative
A thopaz+ pump with serial number (b)(6) was returned to medela ag for a technical analysis.The log file of the thopaz+ pump was downloaded and analyzed.No evidence of the issue could be detected within the log file.The occurrence date was stated to be 04-jul-2023.However, at this date, the pump was in repair at the medela service center from 23-jun-2023 to 01-aug-2023 according to the medela erp system.Therefore, the reported issue with this pump has not been confirmed from medela ag side.Our conclusion was that this pump was not involved in the described incident, as the pump was located in the service center at the time of the incident.Either the hospital sent us a wrong pump for investigation, or they did send us a wrong date of the incident.We¿ve not received any additional information even after sending them many requests for it.

• Brand Name: THOPAZ+ PUMP W/ AC ADAPTOR (1
• 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: 17315893
• Report Number: 3002807523-2023-00011
• Device Sequence Number: 19822757
• Product Code: OMP
• UDI-Device Identifier: 07612367041027
• UDI-Public: 7612367041027
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0791000
• Device Catalogue Number: 0791000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/05/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 10/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male