MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH MICROSTREAM CO2 EXTENSION

Model Number	M3015A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that on (b)(6) 2022 at around 2 pm, there was a co2 equipment malfunction.A patient had a heart episode while connected to the device.The m3015a device was swapped out and sent for bench repair.Bench repair determined that the unit contains non-serviceable parts and the entire unit will require exchange.
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
The catalog number, device name, fda product code and 510k have been corrected in this report.
Event or Problem Description
The customer reported that on (b)(6) 2022 at around 2 pm, there was a co2 equipment malfunction.A patient had a heart episode while connected to the device.The m3015a device was swapped out and sent for bench repair.Bench repair determined that the unit contained non-serviceable parts and the entire unit required exchange.A good faith effort (gfe) was made to determine whether the device caused or contributed to the patient heart episode.However, no further information was provided by the customer.The device had a confirmed malfunction.The investigation was unable to determine any relationship of the device malfunction to the reported event.

• Brand Name: MICROSTREAM CO2 EXTENSION
• Common Device Name: MICROSTREAM CO2 EXTENSION
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15751134
• Report Number: 9610816-2022-00559
• Device Sequence Number: 5784245
• Product Code: DSI
• UDI-Device Identifier: 00884838021556
• UDI-Public: 00884838021556
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K993383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M3015A
• Device Catalogue Number: M3015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2015
• 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: Hospitalization
• Patient Sex: Male