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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT WORN DEVICE TELEMETRY

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PHILIPS MEDICAL SYSTEMS PATIENT WORN DEVICE TELEMETRY Back to Search Results
Model Number M4841A
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Injury (2348)
Event Date 12/16/2020
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

The hospital's biomed reported that on (b)(6) 2020 at approximately 4:45 am a serious injury occurred with a male patient. Details of the incident and patient outcome was requested but the biomed did not provide the information. The biomed noted there was a "no data available" inop that lasted for a period of one hour and 20 minutes.

 
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Brand NamePATIENT WORN DEVICE
Type of DeviceTELEMETRY
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 Key11089989
MDR Text Key225049122
Report Number1218950-2020-08137
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK040357
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 12/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM4841A
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 Received12/22/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/03/2007
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: 12/29/2020 Patient Sequence Number: 1
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