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

Model Number	867041
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported the etco2 is not consistently registering on their intellivue microstream extension.To protect the patient airway, intubation was performed.
Additional Manufacturer Narrative
The means of evaluation is unknown at this time.It is unknown how this issue was resolved.A good faith effort was made to the district service manager along with the field service engineer.Neither contacts were notified or aware of the event reported by the customer.
Event or Problem Description
The customer reported the etco2 is not consistently registering on their intellivue microstream extension.To protect the patient airway, intubation was performed.

• Brand Name: INTELLIVUE MICROSTREAM EXTENSION
• Common Device Name: INTELLIVUE MICROSTREAM 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: 12648133
• Report Number: 9610816-2021-10438
• Device Sequence Number: 1480200
• Product Code: CCK
• UDI-Device Identifier: 00884838083585
• UDI-Public: 00884838083585
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172904
• 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

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: 867041
• Device Catalogue Number: 867041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2018
• 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 Age: 18 MO
• Patient Sex: Male