MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-05 for AMBU KING MASK SIZE 2 manufactured by Ambu, Inc..
[56510674]
Patient Sequence No: 1, Text Type: N, H10
[56510675]
Infant desat to the 30's. Bag/mask turned on. Bag inflated easily. Infant suctioned but remained apneic with hr down to 50s. Started on positive pressure ventilation (ppv) with ineffective peak inspiratory pressure (pip) so bag was switched out. Within seconds of using new bag, infant was properly ventilated and heart rate (hr)/o2 sats returned to normal. Infant was transferred to nicu in open crib on ra. There was a tear in the mask so a seal could not be achieved. The bag was in working order.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5999289 |
| MDR Report Key | 5999289 |
| Date Received | 2016-10-05 |
| Date of Report | 2016-09-29 |
| Date of Event | 2016-08-25 |
| Report Date | 2016-09-29 |
| Date Reported to FDA | 2016-09-29 |
| Date Reported to Mfgr | 2016-09-29 |
| Date Added to Maude | 2016-10-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | AMBU KING MASK |
| Generic Name | MASK, GAS, ANESTHETIC |
| Product Code | BSJ |
| Date Received | 2016-10-05 |
| Model Number | SIZE 2 |
| ID Number | SIZE 2 |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMBU, INC. |
| Manufacturer Address | SANJAY PARIKH 6230 OLD DOBBIN LN STE 250 COLUMBIA MD 21045 US 21045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-05 |