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

Model Number 865241

Device Problem No Audible Alarm (1019)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/31/2022

Event Type  Injury  

Event Description

It was reported that a spo2 failure to alarm on (b)(6) 2022 approx.00:30 am, room 354.The patient required oxygen therapy.The device was used for patient monitoring at the time of the alleged malfunction.The patient required oxygen therapy.

Manufacturer Narrative

Philips received an email from the customers biomed supervisor that a spo2 failure to alarm on (b)(6) 2022 approx.00:30 am, room 354 occured.The customer stated that they evaluated the system and device working as expected the remote support application specialist reviewed all of the provided log files from the customer and provided the following answer to the customer via email: from the clinical audit trail for the dates/times of (b)(6) (0800 hours) and (b)(6) (0030 hours) it appears that the devices did alert, with sound and some silenced or ended if spo2 values fell back within the normal limits.When an alarm occurs at the bedside, the alert is activated within 6-8 seconds at the picix.The information provided and the clinical audit is that the system worked as designed.There was no product malfunction; this is considered a user issue.The remote support specialist reviewed the provided log files and stated that the alarms were seen to have occurred at the piic ix and silenced by the user at the bedsite monitor.

• 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: 14196361
• MDR Text Key: 290062514
• Report Number: 9610816-2022-00202
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838029088
• UDI-Public: 00884838029088
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Biomedical Engineer
• Type of Report: Initial

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: 865241
• Device Catalogue Number: 865241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/26/2020
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 63 KG