MAUDE Adverse Event Report: TRANSCEND TRANSCEND STARTER CPAP

Catalog Number 503042

Device Problem Use of Device Problem (1670)

Patient Problem Cough (4457)

Event Date 01/01/2023

Event Type  malfunction  

Event Description

Customer purchased a transcend mini cpap machine in 2012.They did not realize that the filter needs to be replaced.Customer claimed on a recent trip internationally, the filter disintegrated and oily particles went into their lungs.Customer concerned as to what the filter material is as they were coughing up black particles.Customer concerned they have put themselves at risk of some type of cancer.Customer stated they did not fully read the manual which directs customers to replace the filter.Customer stated the filter has never been replaced, but was washed.There was no report of serious patient harm or injury.There was no report that medical intervention was required.

Manufacturer Narrative

Device was received and investigated.We have tried to report this via webtrader since 01feb2023, but have not been able to get through software issues with the webtrader system.Continued with attempts to obtain more information and getting the device back from the customer.Device received and investigated.Investigation results: device was very dirty, appeared the hose had never been replaced and the entire inside of hose was coated with what appeared to be dirt.Customer informed us they had not followed the instructions for use and had never replaced the filter per the instructions for use.

• Brand Name: TRANSCEND STARTER CPAP
• Type of Device: CPAP
• Manufacturer (Section D): TRANSCEND; 103 osborne road ne; fridley MN 55432
• Manufacturer (Section G): SP MANUFACTURING; citra buana park iii; kelurahan belian, batam, indonesia 29464 ; SN 29464
• MDR Report Key: 16826804
• MDR Text Key: 314127455
• Report Number: 3008770104-2023-00001
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100121
• 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: 02/08/2023

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 503042
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female