MAUDE Adverse Event Report: RESPIRONICS, INC. SIMPLYGO MINI OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number 1113601

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 05/26/2018

Event Type  Injury  

Event Description

The manufacturer received information alleging a simplygo mini oxygen concentrator alarmed and shut down while in patient use.The patient was admitted to the hospital.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be filed when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a simplygo mini oxygen concentrator that allegedly alarmed and shut down while in patient use.The patient was admitted to the hospital.It was confirmed by the reporting facility that the patient did not have a back up supply of oxygen and was taken to the hospital until the dme (durable medical equipment) supplier could replace the device.The device was returned to the manufacturer's service center for evaluation.The customer's complaint was confirmed.The manufacturer reviewed the device's downloaded event log and confirmed an error occurred.The main board was replaced to address the issue.

• Brand Name: SIMPLYGO MINI OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• Manufacturer (Section G): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• Manufacturer Contact: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 7564971
• MDR Text Key: 109905776
• Report Number: 1040777-2018-00024
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032392
• UDI-Public: 00606959032392
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1113601
• Device Catalogue Number: 1113601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR