MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-21 for CPAP TUBING manufactured by Unknown.
[137304109]
Cpap hose that collapses when any bending is present. This is a new problem and it restricts the airway. I have woken to rapid breathing trying to catch my breath since the cpap was not flowing air. Have raised it with the provider and they sent another product that lasted 10 minutes until i turned. I have not suffered impact but others may suffer heart problems. I am unable to find older tubes that would not collapse. Online reviews are reporting this on all new hoses. I am cleaning and reusing my old hose. This should be investigated before someone dies. Bend the hose at the connection and see the thin plastic close up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084343 |
| MDR Report Key | 8367248 |
| Date Received | 2019-02-21 |
| Date of Report | 2019-02-20 |
| Date of Event | 2019-02-19 |
| Date Added to Maude | 2019-02-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CPAP TUBING |
| Generic Name | TUBING, PRESSURE AND ACCESSORIES |
| Product Code | BYX |
| Date Received | 2019-02-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-21 |