MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-14 for ADULT DUAL HEATED WIRE BREATHING SYSTEM 22MM 1.6M KIT 3 038-31-203U 038-32-203U manufactured by Flexicare Medical Dongguan Ltd..
[138761339]
Root cause identified as failure of the seal on the chamber float to function properly as a result of deformation caused by the welding process used during manufacturing. Action taken: training of the operators to identify correct/incorrect assembly/function of stem and seal holder. Introduction of go/no go gauges. New jig that reduces risk of deformation during assembly. 100% inspection on production line.
Patient Sequence No: 1, Text Type: N, H10
[138761340]
The chamber in the 038-31-203u would not fill with water after spiking the bag. The water would not flow into the chamber even after trying to squeeze the water bag. The clip near the spike on the end of the tubing was unclipped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006061749-2019-00007 |
| MDR Report Key | 8419647 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-02-14 |
| Date Mfgr Received | 2019-02-15 |
| Device Manufacturer Date | 2017-05-31 |
| Date Added to Maude | 2019-03-14 |
| 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 | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT DUAL HEATED WIRE BREATHING SYSTEM 22MM 1.6M KIT 3 |
| Generic Name | HEATED WIRE VENTILATOR BREATHING SYSTEM |
| Product Code | BZO |
| Date Received | 2019-03-14 |
| Model Number | 038-31-203U |
| Catalog Number | 038-32-203U |
| Lot Number | 170500532 |
| 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 | 2019-03-14 |