MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-13 for NEO-VENT INFANT RESUSCITATION CIRCUIT 0415 manufactured by Westmed, Inc.
[136859317]
Neo-vent infant resuscitation circuit did not connect to infant resuscitator. Clinician went to use the resuscitation circuit and it would not connect to the panda infant resuscitator. The circuit had previously been able to connect to the resuscitator. Because of this the patient was put at risk and an additional method of resuscitation had to be used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084057 |
| MDR Report Key | 8339477 |
| Date Received | 2019-02-13 |
| Date of Report | 2019-02-12 |
| Date Added to Maude | 2019-02-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEO-VENT INFANT RESUSCITATION CIRCUIT |
| Generic Name | ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE |
| Product Code | BYE |
| Date Received | 2019-02-13 |
| Model Number | 0415 |
| Catalog Number | 0415 |
| Lot Number | 08062018N30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WESTMED, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-02-13 |