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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PATIENT INFORMATION CENTER IX
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PHILIPS NORTH AMERICA LLC PATIENT INFORMATION CENTER IX Back to Search Results
Model Number 866389
Device Problem Defective Alarm (1014)
Patient Problem Ventricular Fibrillation (2130)
Event Date 12/17/2021
Event Type  Injury  
Event Description
The customer biomedical engineer (biomed) reported a failure to alarm for an episode of ventricular fibrillation (vfib), at their philips information center ix (pic ix).The device was in use at time of event, the patient experienced vfib and required resuscitation.
 
Manufacturer Narrative
Phone number (b)(6).A follow up report will be submitted once the investigation is complete.
 
Manufacturer Narrative
The customer stated that a member of the staff was sitting by the monitors, on the phone, at the time and was not alerted to the vfib.A nurse noticed and the patient was successfully resuscitated.A philips field service engineer (fse) went to the customer site.The fse collected screen capture from the mx750 configuration and collected the audit and alarm logs from the pic ix central station and the vital sign report/strip.The fse stated that the configuration of mx750 changed on 26-nov-2021 with the customer present.Changes were made to turn off specific arrythmia alarms and to turn audible and visual latching off at the mx750.These changes were made in an attempt to reduce alarm fatigue.The configuration sign off form was completed by the customer.The fse found there was no failure to alarm.The audit logs indicate that alarms were generated repeatedly at the time of the event.The product support engineer (pse) reviewed the available alarm log files from the intellivue information center (pic ix).The system (monitor and pic ix) correctly alerted the situation on december 16, 2021 at 12:44 p.M.However, the provided alarm strip refers to the **rr alarm at the same time.At 12:47 p.M.The ***vent fib became a ***vtach, which is repeated several times.There was no product malfunction; this is considered a user issue.The engineer performed an evaluation/analysis and determined the device was working as intended with no failures found.Information was provided to the customer to resolve the issue.
 
Event Description
The customer biomedical engineer (biomed) reported a failure to alarm for an episode of ventricular fibrillation (vfib), at their philips information center ix (pic ix).The device was in use at time of event, the patient experienced vfib and required resuscitation.
 
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Brand Name
PATIENT INFORMATION CENTER IX
Type of Device
PATIENT INFORMATION CENTER IX
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer Contact
derek sammarco
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key13059295
MDR Text Key282608009
Report Number1218950-2021-11201
Device Sequence Number1
Product Code MHX
UDI-Device Identifier00884838093041
UDI-Public00884838093041
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K153702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number866389
Device Catalogue Number866389
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/17/2021
Initial Date FDA Received12/22/2021
Supplement Dates Manufacturer Received03/24/2022
Supplement Dates FDA Received04/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient SexMale
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