MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2002-01-04 for PRESSURE EASY * 292004 manufactured by Ipi Medical.
[21391323]
Endotracheal tube cuff burst during inflation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417519-2001-00001 |
| MDR Report Key | 370434 |
| Report Source | 08 |
| Date Received | 2002-01-04 |
| Date of Report | 2001-12-29 |
| Date Mfgr Received | 2001-12-11 |
| Device Manufacturer Date | 2001-08-01 |
| Date Added to Maude | 2002-01-10 |
| 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 | 0 |
| Manufacturer Contact | TERRI DAVIS |
| Manufacturer Street | 6250 SHIER RINGS ROAD |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal | 43016 |
| Manufacturer Phone | 6147915542 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESSURE EASY |
| Generic Name | CUFF PRESSURE MONITOR |
| Product Code | JYJ |
| Date Received | 2002-01-04 |
| Returned To Mfg | 2001-12-11 |
| Model Number | * |
| Catalog Number | 292004 |
| Lot Number | L225 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 359557 |
| Manufacturer | IPI MEDICAL |
| Manufacturer Address | 3217 N. KILPATRICK CHICAGO IL 60641 US |
| Baseline Brand Name | PRESSURE EASY |
| Baseline Generic Name | CUFF PRESSURE MONITOR |
| Baseline Model No | * |
| Baseline Catalog No | 292004 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-01-04 |