MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-08-28 for HUDSON ISO-GARD HEPA LIGHT,CLEAN 28022 manufactured by Teleflex Medical.
[118548963]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[118548964]
Customer complaint alleges "filter in use on expiratory side of vent (servo-i) using 880-36kit circuit. Filter works fine for a few hours and then restricts flow setting off vent alarm. (cont. ) clinician said it acts like a one way valve is closing inside filter. " it was reported there was no patient injury or consequence. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2018-00224 |
| MDR Report Key | 7822777 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-28 |
| Date of Report | 2018-08-10 |
| Date of Event | 2018-08-03 |
| Date Mfgr Received | 2018-10-05 |
| Date Added to Maude | 2018-08-28 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PO BOX 28, KAMUNTING INDUSTRIAL ESTATE |
| Manufacturer City | PERAK, WEST MALAYSIA 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON ISO-GARD HEPA LIGHT,CLEAN |
| Generic Name | FILTER, BACTERIAL, BREATHING-C |
| Product Code | CAH |
| Date Received | 2018-08-28 |
| Catalog Number | 28022 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-28 |