MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-02-25 for ADULT CPAP / HFOT SHIELDED SINGLE LIMB HEATED WIRE BREATHING SYSTEM 1.6M KIT 1 038-31-510U 038-31-501U manufactured by Flexicare Medical Dongguan Ltd..
[138131044]
Device not returned, so tested parts held in stock manufactured at a similar time. Some parts dimensionally incorrect / out of tolerance. Some parts exhibiting flash.
Patient Sequence No: 1, Text Type: N, H10
[138131065]
2 x water chambers part of the 038-31-501u circuit kits would not fill with water on a high flow nasal cannula setup. Water only came partway down the tubing on the first but would not fill the chamber. Complete setup exchanged. Second chamber the line would not even fill.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006061749-2019-00005 |
| MDR Report Key | 8366568 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-02-25 |
| Date of Report | 2019-02-25 |
| Date of Event | 2019-02-06 |
| Date Mfgr Received | 2019-02-07 |
| Date Added to Maude | 2019-02-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR RICHARD DOWNS |
| Manufacturer Street | CYNON VALLEY BUSINESS PARK |
| Manufacturer City | MOUNTAIN ASH, RCT CF454ER |
| Manufacturer Country | UK |
| Manufacturer Postal | CF45 4ER |
| Manufacturer G1 | FLEXICARE MEDICAL DONGGUAN LTD. |
| Manufacturer Street | NO. B-15 XICHENG IND ZONE 1 HENGLI TOWN |
| Manufacturer City | DONGGUAN CITY, GUANGDONG 523460 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 523460 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT CPAP / HFOT SHIELDED SINGLE LIMB HEATED WIRE BREATHING SYSTEM 1.6M KIT 1 |
| Generic Name | SINGLE LIMB HEATED CIRCUIT |
| Product Code | BZO |
| Date Received | 2019-02-25 |
| Model Number | 038-31-510U |
| Catalog Number | 038-31-501U |
| Lot Number | 180601434 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FLEXICARE MEDICAL DONGGUAN LTD. |
| Manufacturer Address | NO. B-15 XICHENG IND ZONE 1 HENGLI TOWN DONGGUAN CITY, GUANGDONG 523460 CH 523460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-25 |