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

Model Number 865240

Device Problem Delayed Alarm (1011)

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

Event Date 08/16/2022

Event Type  malfunction  

Event Description

It was reported that it took 30 seconds for all red alarms to appear on the intellivue mx800 patient monitor, which then caused a delay in sending the alarms to the central station and to the pagers for the nurses in the unit.The device was in use at time of event, there was no adverse event reported.

Manufacturer Narrative

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

Event Description

The customer reported that it took 30 seconds for all red alarms to appear on the intellivue mx800 patient monitor, which then caused a delay in sending the alarms to the central station and to the pagers for the nurses in the unit.The customer wanted to know if the alarms were silenced by themselves or caused by a user.The field service engineer (fse) went to the customer¿s site and determined the logs showed the alarm was silenced at the bed.Additional information has been requested.The device was in use at time of event, there was no adverse event or patient impact was reported.

Manufacturer Narrative

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

Event Description

Problem statement: it was reported that it took 30 seconds for all red alarms to appear on the intellivue mx800 patient monitor, which then caused a delay in sending the alarms to the central station and to the pagers for the nurses in the unit.As the event was reportable to a regulatory authority and indicated a possible failure of a device, labeling, or packaging to meet any of its specifications, an investigation was required.Complaint evaluation: a good faith effort (gfe) was made to get part back for evaluation associated with this complaint evaluation.The customer wanted to know if the alarms were silenced by themselves or caused by a user.The field service engineer (fse), remote service engineer (rse) and reactive planner for the case were all contacted and confirmed that no work was done for the case as it was canceled per the customer.The fse did not go onsite and had no information on the issue further.No logs were pulled or the delay known.Customer resolution and conclusion: all available information has been recorded and no resolution was made since no work was done by either the fse or rse to find a solution.Patient/user involvement was the device being used on a patient at the time of the event, including for the purposes of diagnosis? yes, the device was in use monitoring a patient at the time of the reported event.Was there any adverse event to the patient or user? if yes, describe? no death or patient / user injury or harm was reported.If there was an adverse event, did the device cause or contribute to the adverse event, and how? no death or patient / user injury or harm was reported.

• 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: 15379367
• MDR Text Key: 301120868
• Report Number: 9610816-2022-00479
• 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?: 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
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 08/17/2022; 10/17/2022
• Supplement Dates FDA Received: 10/06/2022; 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2016
• 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