MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-23 for AMBU KING MASK 1025 manufactured by King Systems.
[61151950]
Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[61151951]
As provided to king systems, multiple contacts to request additional information have not yielded any details. Infant desat to the 30s. 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)/02 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 | 1824226-2016-00003 |
| MDR Report Key | 6126192 |
| Date Received | 2016-11-23 |
| Date of Report | 2016-11-23 |
| Date of Event | 2016-08-25 |
| Date Mfgr Received | 2016-10-26 |
| Date Added to Maude | 2016-11-23 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WAYNE NETHERCUTT |
| Manufacturer Street | 15011 HERRIMAN BLVD. |
| Manufacturer City | NOBLESVILLE IN 46060 |
| Manufacturer Country | US |
| Manufacturer Postal | 46060 |
| Manufacturer Phone | 3177763175 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AMBU KING MASK |
| Generic Name | MASK, GAS, ANESTHETIC |
| Product Code | BSJ |
| Date Received | 2016-11-23 |
| Model Number | 1025 |
| Catalog Number | 1025 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KING SYSTEMS |
| Manufacturer Address | 15011 HERRIMAN BLVD. NOBLESVILLE IN 46060 US 46060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-23 |