MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX600 PATIENT MONITOR

Model Number 865242

Device Problem Incorrect Measurement (1383)

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

Event Date 12/28/2021

Event Type  malfunction  

Manufacturer Narrative

Reporter institution phone number: (b)(6).Reporter phone number: (b)(6).A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that they found the o2 saturation measurement to be not accurate.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

Manufacturer Narrative

Additional good faith effort to complete investigation is still pending at this time.A follow up report will be submitted once the investigation is complete.

Manufacturer Narrative

H3 other text : not returned.

Event Description

The customer reported that they found the o2 saturation measurement to be not accurate.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.The philips representatives have not been able to obtain any additional information despite several requests being made.The cause of the event is unknown.It is unknown if the issue was resolved.The device remained on site.

• Brand Name: INTELLIVUE MX600 PATIENT MONITOR
• Type of Device: INTELLIVUE MX600 PATIENT MONITOR
• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13401455
• MDR Text Key: 285016778
• Report Number: 9610816-2022-00052
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838029095
• UDI-Public: 00884838029095
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,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 Model Number: 865242
• Device Catalogue Number: 865242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 08/19/2022; 08/19/2022
• Supplement Dates FDA Received: 09/21/2022; 11/13/2022
• Was Device Evaluated by Manufacturer?: No
• 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