MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-29 for EMERGENT CIRCUIT KIT * manufactured by Plastics Engineering And Development, Inc. (pedi).
[18490685]
The patient was in respiratory distress. Staff placed the continuous positive airway pressure (cpap) mask on the patient. There was good air flow, but no pressure was present to push air into the lungs. The failure of the circuit caused a delay in treatment. When another circuit was used, the situation improved. No further complications occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 887786 |
| MDR Report Key | 887786 |
| Date Received | 2007-06-29 |
| Date of Report | 2007-06-20 |
| Date of Event | 2007-06-14 |
| Report Date | 2007-06-20 |
| Date Reported to FDA | 2007-06-29 |
| Date Added to Maude | 2007-08-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMERGENT CIRCUIT KIT |
| Generic Name | TUBING, CPAP |
| Product Code | NHJ |
| Date Received | 2007-06-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | ERP124-1M/030306 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 865294 |
| Manufacturer | PLASTICS ENGINEERING AND DEVELOPMENT, INC. (PEDI) |
| Manufacturer Address | 2731 LOKER AVENUE WEST CARLSBAD CA 92010 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2007-06-29 |