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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 2.4 GHZ SMART HOPPING
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PHILIPS MEDICAL SYSTEMS MX40 2.4 GHZ SMART HOPPING Back to Search Results
Model Number 865351
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The customer reported that there was no sound from their mx40, as well as the inability to connect to the central station.There was no pt harm reported by the customer.
 
Manufacturer Narrative
Pr#: (b)(4).A follow-up report will be submitted once the investigation is complete.
 
Manufacturer Narrative
Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
Event Description
The customer reported that there was no sound from their mx40, as well as the inability to connect to the central station.There was no patient involvement.
 
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Brand Name
MX40 2.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman rd.
andover, MA 01810
9786593679
MDR Report Key4363402
MDR Text Key5236700
Report Number1218950-2014-07401
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number865351
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/24/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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