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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DETECTOR AND ALARM, ARRHYTHMIA

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PHILIPS MEDICAL SYSTEMS DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Death (1802); Dyspnea (1816); Respiratory Distress (2045)
Event Date 09/08/2017
Event Type  Death  
Event Description

On [date redacted], a patient was brought in by ambulance to the emergency department with shortness of breath. The patient was diagnosed with chronic obstructive pulmonary disease and community acquired pneumonia and was admitted to the medical surgical unit. Next day at 03:30, the patient was transferred to the medical icu (micu) for respiratory deterioration. While in the micu, the patient was agitated, pulling out his lines and leads and attempting to climb out of bed; interventions included haldol, vest and mitt restraints. At 19:35, the patient was found with his ecg leads, oxygen finger probe, and nasal cannula pulled off and he was unresponsive, without a pulse. Code blue was initiated and at 20:21, the patient was pronounced dead. During the investigation, it was found that the patient's monitor alarms were silenced at the central monitor (nurses station) preceding the discovery of the patient being unresponsive. The event was done during shift change during report. Manufacturer response for ekg monitor, (per site reporter): mfr responded by coming to campus and evaluating machine/alarms for both the patient monitor and the central monitor. Full qa check was performed and it was identified, the machines were fully operational.

 
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Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd
andover MA 01810
MDR Report Key6943921
MDR Text Key89143727
Report Number6943921
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/28/2017,09/29/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/12/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/28/2017
Device Age2 yr
Event Location Hospital
Date Report TO Manufacturer09/28/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/12/2017 Patient Sequence Number: 1
Treatment
NO
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