MAUDE Adverse Event Report: UNKNOWN; OXYGEN CONCENTRATOR

Device Problems Device Inoperable (1663); Connection Problem (2900)

Patient Problem Hypoxia (1918)

Event Date 01/16/2017

Event Type  Death  

Event Description

Patient presented to emergency room via ambulance transport after being found in respiratory arrest at her room.Patient was put on 15% non-re breather mask in route to the emergency room.Upon arrival to the emergency room, the patients sats were 94% on 15 liters non-re breather mask.The patient reported she normally uses 6-8 liters of oxygen at home with sats that range from 84%-88%.The emergency room physician called (b)(4) to identify the max setting for the patients home oxygen machine.It was reported to the emergency room physician that after the machine was evaluated by the representative from (b)(4), it was felt that the machine may not be functioning properly and at that time, the machine was replaced with a new unit.Labs and a chest x-ray were performed.The patient was placed on 8 liters of oxygen.The patient was discharged home at 0150 on (b)(6) 2014 and started on zithromax and instructed to follow up with primary care physician or return to the ed for any further concerns.At 0212 the ambulance service received another call regarding this patient for a female not breathing.When the ambulance crew arrived, they initiated cpr.The patient arrived to the emergency room approximate 0300 and resuscitation efforts continued.Resuscitation efforts were stopped and the patient was pronounced dead at 0352.It was explained to the emergency room physician and ambulance crew by a family member that they were home approximately 5-10 min, the patient had to navigate steep stairs to get into her house.The patient became exhausted and short of breath.The family member stated that they had trouble getting her connected to the new home oxygen machine.She thought it took about 10 minutes in this time the patient became unresponsive.The family member went across the street to get the neighbor to assist with cpr.When they came back, the patient was blue unresponsive and off her oxygen.The manufacturer of the oxygen concentrator is not known.The oxygen concentrator was not used or supplied by (b)(4).The home oxygen equipment and services were supplied by (b)(4).

• Brand Name: UNKNOWN
• Type of Device: OXYGEN CONCENTRATOR
• MDR Report Key: 3631604
• MDR Text Key: 4203977
• Report Number: 3631604
• Device Sequence Number: 1
• Product Code: BSO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2014
• Distributor Facility Aware Date: 01/17/2014
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 57 YR
• Patient Weight: 120