MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-04-18 for PED 5 FT DUAL-HTD CIRCUIT RT509-852 manufactured by Cardinal Health.
[736151]
Customer states that a hole was burned on the expiratory limb, about 12 inches from the patient eye. No report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
[8014634]
Unfortunately the sample was thrown out by the customer, therefore we are unable to determine the exact cause for the reported issue. However, samples of the process were reviewed and no problems were found related to the issue reported. A device history record review could not be performed either since a lot number was not reported by the customer. The product label does indicate that objects such as heavy tapes, towels or bed linens may over insulate the circuits, impede normal heat convection, and cause damage to the tubing or interruption of gas delivery to the patient such as in this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2007-00034 |
| MDR Report Key | 943306 |
| Report Source | 05,06 |
| Date Received | 2007-04-18 |
| Date of Report | 2007-04-11 |
| Date of Event | 2007-03-10 |
| Date Mfgr Received | 2007-03-14 |
| Date Added to Maude | 2007-11-14 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN RD. BLDG KB |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PED 5 FT DUAL-HTD CIRCUIT |
| Generic Name | PED 5 FT DUAL-HTD CIRCUIT |
| Product Code | BZB |
| Date Received | 2007-04-18 |
| Model Number | RT509-852 |
| Catalog Number | RT509-852 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 915379 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | * MCGAW PARK IL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-04-18 |