MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH PNEUMOCLEAR¿; LAPAROSCOPIC INSUFFLATOR

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)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The most probable root cause cannot be determined at present due to the insufficient information.As a malfunction of the device cannot be excluded, the event is considered reportable.
Event or Problem Description
We have been informed of the following event: "during the procedure with ref: (b)(4) sn: (b)(4) there was a cardiac arrest.According to medical personnel it was caused by the medical device.Vital functions have been restored.".
Event or Problem Description
We have been informed of the following event: "during the procedure with ref: (b)(4) sn: (b)(6) there was a cardiac arrest.According to medical personnel it was caused by the medical device.Vital functions have been restored.".
Additional Manufacturer Narrative
Affected devices: pneumoclear fm300; serial number: (b)(6).The inital report was filed with fda on 7th july 2022.(mfr# 3002914049-2022-00005).In the meantime t the insufflator fm300 was returned and evaluated.Full functional testing was conducted, and the device was found to be working per specifications.

• Brand Name: PNEUMOCLEAR¿
• Common Device Name: LAPAROSCOPIC INSUFFLATOR
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; alte poststrasse 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: ellen giese ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 14948587
• Report Number: 3002914049-2022-00005
• Device Sequence Number: 17288940
• Product Code: HIF
• UDI-Device Identifier: 04056702003456
• UDI-Public: 04056702003456
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K112642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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
• Device Catalogue Number: 0620050000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• 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: Life Threatening
• Patient Age: 46 YR
• Patient Sex: Male