MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1997-03-18 for WATER TRAP WITH WYE ADAPTER 6691 manufactured by Ipi Medical Products.
[52020]
Two ventilator circuits with adapters were reportedly cracked and broken. Inspection of the returned units confirmed cracks on the water trap cap at the vial insert slots.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417519-1997-00002 |
| MDR Report Key | 78074 |
| Report Source | 08 |
| Date Received | 1997-03-18 |
| Date of Report | 1997-03-13 |
| Date Mfgr Received | 1997-02-13 |
| Device Manufacturer Date | 1996-07-01 |
| Date Added to Maude | 1997-03-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATER TRAP WITH WYE ADAPTER |
| Generic Name | CUSTOM VENTILATOR CIRCUIT COMPONENT |
| Product Code | BYH |
| Date Received | 1997-03-18 |
| Model Number | NA |
| Catalog Number | 6691 |
| Lot Number | F194 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 77711 |
| Manufacturer | IPI MEDICAL PRODUCTS |
| Manufacturer Address | 3217 N KILPATRICK CHICAGO IL 60641 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-03-18 |