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

Model Number 865240

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported that the alarm is not activating correctly for low blood pressure and as a consequence, the patient developed severe hypotension.The blood pressure dropped down to 40s and no alarms went off.It was noted the patient had begun hemorrhaging from her groin and became severely hypotensive with a systolic pressure in the 40s.Vasopressors were increased, a blood transfusion was performed, and the patient remained unstable for hours after the event.The allegation indicates both visual and audible alarms failed, which resulted in the staff not being alerted to the hypotension; however, audit logs indicate there were alarms both visual and audible.It remains unclear as to the cause of the alleged event and investigation is pending.A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

Additional information obtained from product support engineer (pse).The pse indicates the event logs contain evidence of visual and audible yellow alarms, but no evidence any red alarms.However, the pse indicated not all alarm soundings are recorded in the picix protocol.Thus, red alarms may have occurred, but not be documented within the file.So, we are unable to confirm if the device functioned as expected at the time of the event.

Manufacturer Narrative

Philips received a complaint on the intellivue mx800 patient monitor indicating that the device failed to provide red visual or audible alarm when a patient¿s blood pressure dropped to 40 at 17:20 on (b)(6) 2023.Ambulatory blood pressure (abp) low alarm limit was set at 70.Arterial blood pressure (art) low alarm limit was set at 60.The patient began exsanguinating from their groin.As a result, their vasopressors were increased, and they received a mass blood transfusion.A philips field service engineer (fse) went to the customer site.The fse evaluated the monitor.The low and high art and abp alarms functioned as expected at the time of the evaluation and the pressure zeroed fine.The fse verified alarms were heard at speaker located at the surveillance and the remote speaker.But, the fse did indicate that in their opinion the location of the remote speaker could make it difficult for the staff to hear audible alarms.However, the customer stated they believe the location of the speaker and the volume setting are appropriate and were not factors.The event logs were reviewed by philips engineers.The engineers determined at 17:19:38 a visual yellow alarm was generated for arterial blood pressure mean of 58 and an audible sound was given.Additionally, at 17:13:30 yellow visual alarms were generated for arterial blood pressure mean of 33 and arterial blood pressure diastole of 35.No audible alarm are documented for the alarm events that occurred at 17:13:30.However, not all audible alarms are recorded in the pic ix log protocol.So, this is not an indication of alarm failure.The engineers were not able to confirm red alarm functionality due to insufficient information.Alarm log history for the monitor, the alarm log history for the pic ix log protocol, and the pic ix trend protocol would all be needed in order to conclude if a red alarm failure occurred.Results of functional testing indicate the issue could not be recreated and no root cause could be confirmed due to insufficient information.The reported problem was not confirmed.Closure & product disposition: the device was alarming as expected at the time it was evaluated by the fse.Review of event logs confirmed the device provided a yellow visual alarm and an audible alarm on the date and time of the alleged alarm failure.Insufficient information was available to assess red alarm functionality.The investigation concludes that no further action is required at this time.

Event Description

Philips received a complaint on the intellivue mx800 patient monitor indicating that both the audible and visual alarms failed when a patient¿s blood pressure dropped into the 40¿s.As a result the patient received a blood transfusion and was unstable for a few hours after the event.The complaint investigation is still pending.

Manufacturer Narrative

Additional information obtained from product support engineer (pse).The pse indicates the event logs contain evidence of visual and audible yellow alarms, but no evidence any red alarms.However, the pse indicated not all alarm soundings are recorded in the picix protocol.Thus, red alarms may have occurred, but not be documented within the file.We are unable to confirm if the device functioned as expected at the time of the event.

• 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: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 16278605
• MDR Text Key: 308610229
• Report Number: 9610816-2023-00056
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• 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
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2020
• 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): Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 72 KG