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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX800 PATIENT MONITOR
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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX800 PATIENT MONITOR Back to Search Results
Model Number 865240
Device Problem No Audible Alarm (1019)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 06/25/2021
Event Type  Injury  
Event Description
The customer reported that the intellivue mx800 patient monitor did not alarm for "ecg leads off" on (b)(6) 2021 at 05:40 for the patient in room 7216.The device was in use monitoring a patient at the time of the reported event.An adverse event was reported.Despite the attempt to obtain additional details regarding the type of adverse event, the medical steps taken to assist the patient, and the patient details, such as gender, age, height, and weight, no further information was made available by the customer.
 
Manufacturer Narrative
A philips field service engineer (fse) went onsite to test the mx800.The monitor worked as intended and no trouble was found with the device.Additionally, the fse collected the audit log from the central station as well as the status/device report for the monitor.The provided logs were forwarded to philips product support engineering (pse) for analysis.During the investigation pse found that only one of the provided logs contained the date of the event (b)(6) 2021.Looking at the specific log, several "ecg leads off", "rl lead off" and "respiration leads off" inops were generated between 05:41:15 and 05:41:30 for the patient in room 7216.The customer was advised of the investigation result by letter.The monitor worked as intended and there was no malfunction of the device.This issue was caused by user error.
 
Event Description
The customer reported that the intellivue mx800 patient monitor did not alarm for "ecg leads off" on (b)(6) 2021 at 05:40 for the patient in room 7216.The device was in use monitoring a patient at the time of the reported event.An adverse event was reported.Despite the attempt to obtain additional details regarding the type of adverse event, the medical steps taken to assist the patient, and the patient details, such as gender, age, height, and weight, no further information was made available by the customer.
 
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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
MDR Report Key12177728
MDR Text Key261885956
Report Number9610816-2021-10229
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00884838020733
UDI-Public00884838020733
Combination Product (y/n)N
PMA/PMN Number
K150310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
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 Number865240
Device Catalogue Number865240
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date06/25/2021
Initial Date Manufacturer Received 06/25/2021
Initial Date FDA Received07/15/2021
Supplement Dates Manufacturer Received06/25/2021
Supplement Dates FDA Received08/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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