MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER X2

Model Number 865039

Device Problem Failure to Sense (1559)

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

Event Date 06/13/2021

Event Type  malfunction  

Manufacturer Narrative

Reporter phone number (b)(6).

Event Description

The customer reported that on the intellivue multi measurement server x2 the spo2 measuement stoped.No information was given as to whether or not a inop occured.The device was used for patient monitoring at the time of the alleged malfunction.No adverse event involving a patient or user was reported.

Event Description

The customer reported that on the intellivue multi measurement server x2 the spo2 measurement stopped.No information was given as to whether or not a inop occured.The device was used for patient monitoring at the time of the alleged malfunction.No adverse event involving a patient or user was reported.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Type of Device: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• MDR Report Key: 12141679
• MDR Text Key: 260782067
• Report Number: 9610816-2021-10208
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000261
• UDI-Public: 00884838000261
• Combination Product (y/n): N
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 865039
• Device Catalogue Number: 865039
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/13/2021
• Initial Date Manufacturer Received: 06/13/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 06/13/2021
• Supplement Dates FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1