MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for NEO-FIT NEONATAL ENDOTRAC 42-2540 manufactured by Coopersurgical, Inc..
[135169617]
Coopersurgical, inc. Is currently investigating the reported complaint condition. Once the investigation is completed a follow up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[135169618]
(b)(4). Vent alarmed low min. Volume patient desaturation no sensor pick up bradycardia -bagged- no etl o2. Please note additional complaints also filed for reported condition. In all of the events, this is varied. Some happened outside of any event or procedure and with a sleeping patient laying supine in bed. Some occurred with vomiting, bathing, kangaroo care, before, during, or after these procedures. Tube at different marking at gum or lip, desaturation, tube visually moving, ventilator alarms, not sensing breaths on ventilator, no chest movement. Patients required reintubation and received chest x-ray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2019-00021 |
| MDR Report Key | 8306133 |
| Date Received | 2019-02-05 |
| Date of Report | 2019-11-11 |
| Date of Event | 2018-12-17 |
| Date Mfgr Received | 2019-01-22 |
| Device Manufacturer Date | 2017-12-07 |
| Date Added to Maude | 2019-02-05 |
| 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 | MR. PETER NIZIOLEK |
| Manufacturer Street | 50 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC, |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEO-FIT NEONATAL ENDOTRAC |
| Generic Name | NEO-FIT |
| Product Code | JAY |
| Date Received | 2019-02-05 |
| Model Number | 42-2540 |
| Catalog Number | 42-2540 |
| Lot Number | 234581 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-02-05 |