MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2008-03-13 for EXH VLV ASSY, PED, MILL, ENGLISH 21442-1 manufactured by Sechrist Industries, Inc..
[15159279]
Distributor in (b) (4) reported that customer at hospital apparently attempted to use ventilator with reference pressure line stuck into a threaded hole in the front of the pediatric exhalation block. The pediatric exhalation block is used to ventilate pts ranging from 10 lbs to 100 lbs, not neonates or premature infants. The threaded hole is plugged with at least two setscrews to prevent full insertion of the sense line. The reference pressure connector is designed to be a tapered slip fit into a smooth side tapered hole in the lower front of the block. The block label clearly identifies the holes the proximal line, reference pressure line and "from pt" hose connections are to be made into.
Patient Sequence No: 1, Text Type: D, B5
[15172702]
Appears to be user error. Follow up report will be submitted for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020676-2008-00003 |
| MDR Report Key | 1016373 |
| Report Source | 01,06,08 |
| Date Received | 2008-03-13 |
| Date of Report | 2008-03-13 |
| Date of Event | 2008-02-04 |
| Date Facility Aware | 2008-02-18 |
| Date Mfgr Received | 2008-02-12 |
| Device Manufacturer Date | 2000-09-01 |
| Date Added to Maude | 2009-12-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GREG GODFREY |
| Manufacturer Street | 4225 EAST LA PALMA AVE. |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal | 92807 |
| Manufacturer Phone | 7145798400 |
| Manufacturer G1 | SECHRIST INDUSTRIES, INC. |
| Manufacturer Street | 4225 EAST LA PALMA AVE. |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92807 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXH VLV ASSY, PED, MILL, ENGLISH |
| Generic Name | PEDIATRIC EXHALATION VALVE |
| Product Code | CBP |
| Date Received | 2008-03-13 |
| Model Number | 21442-1 |
| Catalog Number | 21442-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | ANAHEIM CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-13 |