MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX800 PATIENT MONITOR

Model Number 865240

Device Problem No Audible Alarm (1019)

Patient Problems Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the intellivue mx800 patient monitor did not alarm for a desaturation event on (b)(6) 2022 between 01:00 and 07:00 for a neonatal patient in nicu.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.

Manufacturer Narrative

This case was initially reported as a product problem but was updated to serious injury.Sections b and h were updated.

Event Description

It was reported that the neonatal patient lost consciousness.

Manufacturer Narrative

A philips field service engineer (fse) went to the customer site and collected the clinical audit log and status / configuration report for the mx800 which were forwarded to philips product support engineering (pse) for analysis.During the evaluation of the log, it was found that the data in the provided log did not start until 03:42 on (b)(6) 2022 and did not cover the complete time frame reported by the customer.The bed with label 2444b was not found in the provided logs.In addition, the alarm review from the bedside monitor and the trend data review from the central station were not made available for analysis.While onsite, the fse checked the performance of the monitor and found the mx800 to be working as intended.No trouble was found with the dev ice.Based on the data provided, the exact cause for the reported issue could not be established.

• Brand Name: INTELLIVUE MX800 PATIENT MONITOR
• Type of Device: INTELLIVUE MX800 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14278500
• MDR Text Key: 295047359
• Report Number: 9610816-2022-00222
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838020733
• UDI-Public: 00884838020733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150310
• 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,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
• Device Operator: Health Professional
• Device Model Number: 865240
• Device Catalogue Number: 865240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 06/10/2022; 08/22/2022
• Supplement Dates FDA Received: 07/05/2022; 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2017
• 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