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

Model Number 867041

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2022

Event Type  malfunction  

Event Description

It was reported that the module intermittently stops working by freezing or losing power.The device was not in clinical use.

• 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: 14688933
• MDR Text Key: 294657318
• Report Number: 9610816-2022-00329
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• 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: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2019
• 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