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

Model Number 867041

Device Problem Intermittent Communication Failure (4038)

Patient Problem Respiratory Insufficiency (4462)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported the etco2 is not consistently registering on their intellivue microstream extension.To protect the patient airway, intubation was performed.

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 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
• Type of Device: 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
• MDR Text Key: 276897888
• Report Number: 9610816-2021-10438
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 00884838083585
• UDI-Public: 00884838083585
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 867041
• Device Catalogue Number: 867041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 MO
• Patient Sex: Male