MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-04 for BREATHE TECH BT 2026 manufactured by Sunmed.
[132567587]
Defective ambu bag - intubated pt needing to be bagged. Ambu bag in pt's room was a breath tech bt 2000 (blue color with peep valve already attached). Pt was actively being bagged and was decompensating (heart rate decreasing to 60's and oxygen saturations decreasing). Attending, 2 respiratory therapist, pediatric nurse practitioner, charge rn, bedside rn present. Multiple interventions attempted such as suctioning and re-intubation. Pt decompensated to the point of needing resuscitation for approx 5 min. Epinephrine given x 1 and atropine given x 2. Ambu bag switched to another brand device and pt compliance improved. Once pt stabilized, it was discovered that pop off valve for breath tech 2000 ambu bag was releasing before reaching pressures of 40, therefore, pt was not receiving the pressures needed during bagging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8230666 |
| MDR Report Key | 8230666 |
| Date Received | 2019-01-04 |
| Date of Report | 2019-01-03 |
| Date of Event | 2018-12-28 |
| Date Facility Aware | 2019-01-03 |
| Report Date | 2019-01-03 |
| Date Added to Maude | 2019-01-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATHE TECH |
| Generic Name | BREATHE TECH |
| Product Code | NHK |
| Date Received | 2019-01-04 |
| Model Number | BT 2026 |
| Lot Number | 314571 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNMED |
| Manufacturer Address | 36 W ROUTE 70 STE 214 MARLTON NJ 08053 US 08053 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-01-04 |