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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

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PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING Back to Search Results
Model Number 865350
Device Problem Device Alarm System (1012)
Patient Problem Loss of consciousness (2418)
Event Date 08/17/2017
Event Type  Injury  
Manufacturer Narrative

A follow up report will be submitted once the investigation is complete. Serial number not provided. Medwatch number (b)(4).

 
Event Description

The customer reported that a patient felt that he passed out. The patient was showing ventricular standstill on the monitor but the telemetry failed to provide a red alarm. The patient was transferred to a higher level of care for ventricular standstill. The patient was discharged on (b)(6) 2017. The information indicates that urgent medical interventions may have been required. If alarms are delayed, harm is possible. The patient was showing ventricular standstill on the monitor but the telemetry failed to provide a red alarm. The patient was transferred to a higher level of care for ventricular standstill.

 
Manufacturer Narrative

Based on the limited available information we cannot determine the cause or resolution of the reported issue. The customer filed a medwatch, with no direct to call to philips. Several attempts were made to the customer for additional information, with no additional responses. Philips received some additional information from the customer regarding the patient information. Device testing answers were written as "unknown". Philips will consider that the device may have been a factor in the incident with the patient based on the fact that insufficient details were provided to confirm the device was not a factor.

 
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Brand NameMX40 1.4 GHZ SMART HOPPING
Type of DeviceMX40 1.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6986353
MDR Text Key90506391
Report Number1218950-2017-07426
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation RISK MANAGER
Type of Report Initial,Followup
Report Date 10/04/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/30/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number865350
Device LOT NumberCUSTOMER DID NOT PROVIDE
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/04/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/30/2017 Patient Sequence Number: 1
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