MAUDE Adverse Event Report: NULL; GENERATOR, OXYGEN, PORTABLE

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

Brand name information is unknown.Catalog number is unknown.Udi information is unknown.Manufacturing site address is unknown.Premarket (510k) number is unknown.A device history record (dhr) review was conducted by the supplier site.A product sample was received for evaluation at the supplier site.Visual and functional testing were performed by the supplier this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the device would not power on.No patient injury was reported.

• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section G): NULL
• MDR Report Key: 15595771
• MDR Text Key: 307180683
• Report Number: 3012307300-2022-20052
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1