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

Model Number 865240

Device Problem Device Alarm System (1012)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

Problem statement: the customer requested onsite assistance to pull logs for the period of september 21, 2022 at 1900 hours thru september 22, 2022 at 0730 hours to confirm if the alarm from the bedside was silenced.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.Evaluation: pending.Resolution and conclusion: pending.

Manufacturer Narrative

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

Event Description

The customer requested onsite assistance to pull logs for the period of (b)(6) 2022 at 1900 hours thru (b)(6), 2022 at 0730 hours to confirm if the alarm from the bedside was silenced.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.A good faith effort (gfe) was sent for verification of the failure to alarm at the monitor; however, no information was provided by the field service engineer (fse).The technical consultant (tc) assigned to the case responded indicating due to the time in which the incidents occurred and when it was called in, the logs were not able to be obtained for this case.There was no additional information provided.Gfes were made to obtain the clinical audit logs from the central station and status/configuration report from the mx800, but has been unsuccessful.As the requested data was not provided, an investigation was not possible and the exact cause for the reported event could not be determined.The fse reported the issue was resolved a month ago with no further detail provided.It is unknown if the device failed to meet specifications.

• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15555625
• MDR Text Key: 301563793
• Report Number: 9610816-2022-00515
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2021
• 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