MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-08-19 for HUDSON AQUAPAK 1028 SW,1070 ML W/028 ADAPTOR 041-28 manufactured by Teleflex Medical.
[154780366]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[154780367]
The complaint is reported as: "the pacu staff stated that once the product was set up they would turn on the oxygen and they would notice it starting to leak. Once the patient was in recovery and they restarted it up again the leaking started to increase. " the product was not used on the patient. The condition of the patient is reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417411-2019-00036 |
| MDR Report Key | 8907611 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-08-19 |
| Date of Report | 2019-08-02 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2019-10-04 |
| Device Manufacturer Date | 2019-02-11 |
| Date Added to Maude | 2019-08-19 |
| 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 |
| 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 | 900 WEST UNIVERSITY DR. |
| Manufacturer City | ARLINGTON HEIGHTS IL 60004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON AQUAPAK 1028 SW,1070 ML W/028 ADAPTOR |
| Generic Name | HUMIDIFIER NEBULIZER KIT |
| Product Code | OGG |
| Date Received | 2019-08-19 |
| Returned To Mfg | 2019-08-13 |
| Catalog Number | 041-28 |
| Lot Number | 19J009 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-19 |