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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 Low Readings (2460)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2021
Event Type  malfunction  
Event Description
The hospital's nurse manager reported that on (b)(6) 2021, a monitor was reading extremely low spo2 which led to an abg (arterial blood gas) being performed and the patient receiving oxygen.Upon assessment, the low spo2 was determined to be a false reading.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
 
Event Description
The hospital's nurse manager reported that on (b)(6) 2021, a monitor was reading extremely low spo2 which led to an abg (arterial blood gas) being performed and the patient receiving oxygen.Upon assessment, the low spo2 was determined to be a false reading.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
 
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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 Key11604244
MDR Text Key243429394
Report Number1218950-2021-10255
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number865350
Device Catalogue Number865350
Was Device Available for Evaluation? No
Distributor Facility Aware Date03/08/2021
Initial Date Manufacturer Received 03/08/2021
Initial Date FDA Received04/01/2021
Supplement Dates Manufacturer Received03/08/2021
Supplement Dates FDA Received06/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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