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

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.

• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 6943921
• MDR Text Key: 89143727
• Report Number: 6943921
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• 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 Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Death
• Patient Age: 78 YR