MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH PNEUMOCLEAR; CARBON DIOXIDE INSUFFLATOR FOR LAPAROSCOPY AND VESSEL HARVESTING

Model Number	FM300
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Type of Reportable Event	Serious Injury
Event or Problem Description
We have been informed of the following event: "patient heart stopped while doing surgery device was being used patient made it through surgery salesforce case number (b)(4).How was issue noticed: during.Procedure compl successfully: yes.Patient involvement: yes - impact - see adverse consequences.Medical intervention: complainant not aware.Surgical delay: yes.Adverse consequences: patient.Adverse consequences details: patient heart stopped while doing surgery device was being used patient made it through surgery.Surgical delay length: not reported.".
Additional Manufacturer Narrative
The event description is very poor and general.Preventive maintenance of the device has been overdue.At the time of the reporting decision the device was not returned for evaluation.With this limited information the most probable root cause could not be determined.However, in the event description there is no reported evidence or claims, that the device did not work according to its specifications or malfunctioned in any manner which could have contributed to patient's heart stopped (presumably a cardiac arrest).The patient made it through the surgery and no further complications were reported.Nevertheless, on a conservative approach, since we cannot completely exclude a malfunction of the device, this event is considered as reportable.If new information is received, or if the device is returned for evaluation, the reporting decision will be re-evaluated accordingly.
Event or Problem Description
We have been informed of the following event: "patient heart stopped while doing surgery device was being used.The patient made it through surgery and the procedure was completed successfully.".
Additional Manufacturer Narrative
The inital report was filed with fda on 21st july 2025.(mfr# 3002914049-2025-00002).In the meantime, the affected insufflator returned to the manufacturer for investigation and evaluated.Full functional testing was conducted and the device was found to be working as per specifications.Therefore, a causal relationship between the serious incident and the device could not be established.

• Brand Name: PNEUMOCLEAR
• Common Device Name: CARBON DIOXIDE INSUFFLATOR FOR LAPAROSCOPY AND VESSEL HARVESTING
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; w.o.m. world of medicine gmbh; salzufer 8; berlin, berlin 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; alte poststrasae 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: sushira panchama ; w.o.m. world of medicine gmbh; salzufer 8; berlin, berlin 10587 ; GM 10587
• MDR Report Key: 22553697
• Report Number: 3002914049-2025-00002
• Device Sequence Number: 18531617
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 010405670200130811201203
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K201361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: FM300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown