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 2017-09-01 for CABLE, IBP, SINGLE, ARGON, 3.6 M 2016995-001 manufactured by Vyaire Medical, Inc.
[84318883]
Initial mdr submission. At this time, the customer has not provided the sample for evaluation. If additional information becomes available a follow up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[84318884]
The patient was in icu and his invbp values dropped down unexpectedly. The patient has got noradrenalin and his invasive bp was monitored. When the values dropped down the patient got more noradrenalin but there wasn? T any response to that. Bp curve was clear all the time. Then the bp reset to zero and after that the values were high. Then noradrenalin infusion was decreased. And even if support medication was decreased the bp values were increased. Infusion set and cable was detached from one another and bp was reset to zero. After that the bp values were normal for a while but then rose again. Finally cable was changed to a new one and after that the values were stable. Patient was in sleep all the time and his status was stable. Because of that abnormal fluctuations in invbp values were strange. Increased bp would be dangerous for this patient. The invbp values were not reliable and it was impossible to know the real inv bp. Intervention: more noradrenalin given based on inv bp readings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010838917-2017-00037 |
| MDR Report Key | 6837524 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-01 |
| Date of Report | 2018-01-30 |
| Date of Event | 2017-07-22 |
| Date Mfgr Received | 2018-01-19 |
| Date Added to Maude | 2017-09-01 |
| 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 | 2017-09-01 |
| 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 | 2017-09-01 |