MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-17 for HUDSON ISO-GARD HEPA,SMALL STRAIGHT 28062 manufactured by Teleflex Medical.
[117833379]
(b)(4). No oxygen saturation numerical value was reported. The device involved has not been received for evaluation at the time of this report. The investigation is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[117833380]
Customer complaint alleges that "the patient had a surgery under general anesthesia. At the end of the intervention, the ventilatory pressures increased suddenly, so the ventilation became impossible". Clinical consequence reported: the patient desaturated 30% during 1 {one} minute. There was a lack of "tital volumne," no capnography. A bronchospasm was considered. The patient was extubated after surgery and the patient is fine now. Interventions reported: deeping of anesthesia and ventolin did not resolve the issue. The intubation was changed but with no success. The filter was then replaced which resulted in the return of proper ventilation of the patient and quick re-saturation. Customer concluded "overall, the increase of the pressures was induced by the completely clogged antibacterial filter. The occlusion is due because of the moisture between the patient and the filter. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2018-00213 |
| MDR Report Key | 7794150 |
| Date Received | 2018-08-17 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-09-21 |
| Date Added to Maude | 2018-08-17 |
| 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 | 0 |
| Brand Name | HUDSON ISO-GARD HEPA,SMALL STRAIGHT |
| Product Code | CAH |
| Date Received | 2018-08-17 |
| Returned To Mfg | 2018-09-06 |
| Catalog Number | 28062 |
| Lot Number | UNKNOWN |
| 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 | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-17 |