MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-20 for EASY-FLEX 6' CPAP TUBING EASY-FLEX6 N/A manufactured by Worldcross Industries Co., Ltd..
[62846859]
The customer said the end-user had the cpap tubing hooked up to a ventilator - the patient/end-user's son walked into his bedroom and noticed that his dad (the end-user) was lethargic and turning blue, with no response from his dad. The son noticed that the end-user (his dad) was not getting any air from the tubing, as it had collapsed, so he switched it out with new tubing and then his dad started to become more responsive. The end-user's family called our customer the next morning to explain the incident, and said the dad was back to how he normally is. Compass health brands customer service representative called the customer to explain that cpap tubing should not be used on ventilators.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2016-00015 |
| MDR Report Key | 6189642 |
| Date Received | 2016-12-20 |
| Date of Report | 2016-12-20 |
| Date Facility Aware | 2016-12-01 |
| Report Date | 2016-12-20 |
| Date Reported to FDA | 2016-12-20 |
| Date Reported to Mfgr | 2016-12-20 |
| Date Added to Maude | 2016-12-20 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | EASY-FLEX 6' CPAP TUBING |
| Generic Name | CPAP TUBING |
| Product Code | GAZ |
| Date Received | 2016-12-20 |
| Model Number | EASY-FLEX6 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WORLDCROSS INDUSTRIES CO., LTD. |
| Manufacturer Address | NO. 8 YUANSHAN ROAD HEGDIAN ELECTRONIC INDUSTRY PA DONG YANG ZHEJIANG, N/A 322118 CH 322118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-20 |