MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2020-01-06 for GIBECK ISO-GARD FILTER SMALL S, TETHERED CAP IPN043788 19512TN manufactured by Teleflex Medical Sdn. Bhd..
[173780488]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[173780489]
Customer reported the patient's tidal volume decreased to 250 mls and sao2 to 96% resulting in a drop in blood pressure to 89/40 and increased co2 to 9. 5 kpa (kilopascal). The filter was changed and the issue resolved. No further issues or injury to patient reported after filter was changed. Patient was reported to be in critical condition due to a c4 complete tetraplegia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2020-00004 |
| MDR Report Key | 9553341 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2020-01-06 |
| Date of Report | 2019-12-18 |
| Date of Event | 2019-12-06 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-01-06 |
| 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 SDN. BHD. |
| Manufacturer Street | LOT NO : PT2577 JALEN PERUSAHAAN 4 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 | GIBECK ISO-GARD FILTER SMALL S, TETHERED CAP |
| Generic Name | BREATHING CIRCUIT BACTERIAL FILTER |
| Product Code | CAH |
| Date Received | 2020-01-06 |
| Returned To Mfg | 2020-01-03 |
| Model Number | IPN043788 |
| Catalog Number | 19512TN |
| Lot Number | 201932 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL SDN. BHD. |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-06 |