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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Loss of consciousness (2418)
Event Date 06/25/2019
Event Type  Injury  
Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

 
Event Description

It was reported that the hospital staff changed the telemetry battery at approximately 10:10 with green displayed for fully charged battery. The device was not in use on a patient at that time. Subsequently the telemetry device was attached to the patient and the patient was found unresponsive. There was medical intervention performed. No further information is currently available.

 
Manufacturer Narrative

The device is not being returned to philips for evaluation; therefore, the cause of this specific case remains cannot be confirmed at this time. The logs provided showed there was an empty battery alarm generated at 8:20 and another at 8:32 and again at 8:41. There was a ¿battery empty¿ alarm generated at 10:52 and this is when it looks like the battery dies. There is no evidence in the logs that the battery was ever replaced. The device has not been received for evaluation; therefore, the cause of this specific case remains cannot be confirmed at this time. The root cause of the allegation of failure to alarm is unknown due to insufficient information. The event is considered reportable based on the customer allegation of failure to alarm. The device was requested to bench repair, but has not been returned to philips as of 09 sep 2019 for further evaluation. In the event that the device is returned, the record shall be reopened for further evaluation. The customer's biomed department has tested this device and it appears to be working within specifications.

 
Event Description

It was reported that the hospital staff changed the telemetry battery at approximately 10:10 with green displayed for fully charged battery, when the patient was not on the ward at the time. The telemetry device was attached to the patient when the patient came back to the ward. Subsequently, the patient was found unresponsive. The patient was treated by the medical emergency team and was transferred to the intensive care unit (icu).

 
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Brand NameMX40 2.4 GHZ SMART HOPPING
Type of DeviceMX40 2.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8758802
MDR Text Key149969238
Report Number1218950-2019-04822
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 06/28/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number865351
Device Catalogue Number865351
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/28/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/22/2018
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: 07/03/2019 Patient Sequence Number: 1
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