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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 1.4 GHZ SMART HOPPING
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PHILIPS NORTH AMERICA LLC MX40 1.4 GHZ SMART HOPPING Back to Search Results
Model Number 865350
Device Problem No Device Output (1435)
Patient Problem Cardiac Arrest (1762)
Event Date 04/20/2021
Event Type  Injury  
Event Description
A nurse manager reported that on (b)(6) 2021 from approximately 8:30am-12:42pm, there appeared to be no ecg data.The leadset unplugged condition lasted for greater than 3 hours.When the patient was reconnected, resuscitation was necessary.
 
Event Description
A nurse manager reported that on (b)(6) 2021 from approximately 8:30am-12:42pm, there appeared to be no ecg data.The leadset unplugged condition lasted for greater than 3 hours.When the patient was reconnected, resuscitation was necessary.
 
Manufacturer Narrative
The philips field service engineer (fse) secured log files to include intellivue information center (piic) audit logs as well as mx40 logs.While onsite, the fse performed tests and checked behavior and leadset unplugged response.The fse noted a previously configured blue inop sector alert and changed the inop severity to yellow.According to the fse, the mx40 is working as intended.Our philips product support engineer (pse) reviewed and provided an assessment of the piic and mx40 log data provided by the fse.According to the pse, the mx40 logs were incomplete and did not contain the pwm log data.The audit log.Xml file contained information for the incident timeframe and shows alarms related to spo2t no sensor, la lead off, ecg leads off, ressp lead off just prior to the ¿leadset unplugged¿ inop which was generated at 08:36:31 on (b)(6) 2021.According to the pse, the ¿leadset unplugged¿ inop was not acknowledged (by a user) until 12:11:59 on(b)(6) 2021.Moreover, the ¿spo2t no sensor¿ and ¿leadset unplugged¿ inops would have been displayed at the patient sector until the time they were acknowledged (silenced) by a user.Based on philips¿ review of the logs, the devices were determined to be working as designed.The investigation was provided to the reporter.The device remains at the customer site.
 
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Brand Name
MX40 1.4 GHZ SMART HOPPING
Type of Device
MX40 1.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
MDR Report Key11848160
MDR Text Key251396046
Report Number1218950-2021-10561
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00884838082236
UDI-Public00884838082236
Combination Product (y/n)N
PMA/PMN Number
K113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number865350
Device Catalogue Number865350
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date04/21/2021
Date Manufacturer Received04/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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