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

Model Number	M3015A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/29/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
It was reported a patient caused physical damage to the device.As a result, there was a loss of life due to device shortage at the customer site.The device was not in clinical use and a patient death was reported.
Additional Manufacturer Narrative
The product associated with the event was returned and evaluation / analysis was performed.The engineer determined the issue was associated with the spo2 not working, the non-invasive blood pressure (nibp) pump leaking, along with the display bezel and side have cracks.Additionally, the handle kit and battery case are broken.The customer was provided a quote for parts/services.It is unknown how the issue was resolved.The customer has denied the quote provided, therefore the device will be returned, unrepaired, back to the customer site.
Event or Problem Description
It was reported a patient caused physical damage to the device.As a result, there was a loss of life due to device shortage at the customer site.The device was not in clinical use and a patient death was reported.

• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13315302
• Report Number: 9610816-2022-00034
• Device Sequence Number: 1508303
• Product Code: DSI
• UDI-Device Identifier: 00884838021556
• UDI-Public: 00884838021556
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M3015A
• Device Catalogue Number: M3015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 03/11/2022
• 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: Death
• Patient Sex: Unknown