MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX700 PATIENT MONITOR

Model Number 865241

Device Problem Incorrect Measurement (1383)

Patient Problem Hypothermia (1915)

Event Date 12/10/2021

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

It was reported that there was a discrepancy in the temperature measurement.The device was used for patient monitoring at the time of the alleged malfunction.Grade 1 hypothermia and the child was intubated 1h30 minutes longer than anticipated.

Event Description

It was reported that there was a discrepancy in the temperature measurement.The device was used for patient monitoring at the time of the alleged malfunction.Grade 1 hypothermia and the child was intubated 1h30 minutes longer than anticipated.

Manufacturer Narrative

A philips field service engineer (fse) went to the customer site.The customer was advised that the temperature and electrical safety tests performed on the system had given results within the manufacturers' standards.It was found that the temperature cable could come out of its connector slightly if it was pulled.It was also found that if the cable was not perfectly inserted in its connector then a wrong value would be displayed on the monitor.Furthermore the customer was informed about this and reminded to be vigilant about the correct connection of the cable to the module.The reason (as stated by the customer) for the child¿s temperature dropping was due to the warming device not being set correctly ''mistakenly set to room air during the operation`` unable to confirm.The engineer performed an evaluation and determined the device was working as intended with no failures found.The customer was reminded about the correct use of the thermometer by making sure that it s cable was always connected.

• Brand Name: INTELLIVUE MX700 PATIENT MONITOR
• Type of Device: INTELLIVUE MX700 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: 13047810
• MDR Text Key: 282959252
• Report Number: 9610816-2021-10557
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838029088
• UDI-Public: 00884838029088
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Nurse
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865241
• Device Catalogue Number: 865241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2014
• 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): Hospitalization