MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-08-30 for CABLE, IBP, SINGLE, ARGON, 3.6 M 2016995-001 manufactured by Vyaire Medical, Inc.
[83963786]
Initial mdr submission. To date no sample has been provided from the customer. If additional information becomes available a follow up submission will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83963787]
The patient was in icu and has a serious ards (? ) and he/she was turned to the prone position. Soon after that invbp values were very high. Because of that noradrenalin infusion was stopped and fentanyl and propofol was started. When noradrenalin was stopped the invbp curve had disappeared suddenly. Because the next bp value (also nibp measuring was started) was 40/20. Noradrenalin infusion was started again. Then a trunk cable was changed to a new one and values became normal and the bp curve was reliable. No patient injury has been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010838917-2017-00036 |
| MDR Report Key | 6830010 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-30 |
| Date of Report | 2018-01-30 |
| Date of Event | 2017-07-24 |
| Date Mfgr Received | 2018-01-19 |
| Date Added to Maude | 2017-08-30 |
| 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 | MINDY FABER |
| Manufacturer Street | 26125 NORTH RIVERWOODS BLVD. |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer G1 | TECHNICAL SERVICES FOR ELECTRONICS |
| Manufacturer Street | 2F, NO. 21 JIANKANG ROAD JHONGHE DISTRICT |
| Manufacturer City | CHUNG HO CITY, TAIPEI |
| Manufacturer Country | TW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CABLE, IBP, SINGLE, ARGON, 3.6 M |
| Generic Name | DISPLAY, CATHODE-RAY TUBE, MEDICAL |
| Product Code | DXJ |
| Date Received | 2017-08-30 |
| Catalog Number | 2016995-001 |
| Lot Number | 201503K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | 26125 NORTH RIVERWOODS BLVD. METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-30 |