MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-10-06 for P-SERIES 7001-0002-00 manufactured by Compumedics Limited.
[17371310]
Customer called and reported that when the pt returned the unit they informed the technician that the finger probe (nonin probe oximeter) burned their finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613619-2004-00002 |
| MDR Report Key | 547549 |
| Report Source | 05 |
| Date Received | 2004-10-06 |
| Date of Report | 2004-10-05 |
| Date of Event | 2004-09-27 |
| Date Mfgr Received | 2004-09-27 |
| Date Added to Maude | 2004-10-08 |
| 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 | GORDON FERGUSON |
| Manufacturer Street | 30-40 FLOCKHART |
| Manufacturer City | ABBOTSFORD, MELBOURNE 3067 |
| Manufacturer Country | AS |
| Manufacturer Postal | 3067 |
| Manufacturer Phone | 6138420-73 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | P-SERIES |
| Generic Name | SLEEP MONITORING SYSTEM |
| Product Code | LEL |
| Date Received | 2004-10-06 |
| Model Number | 7001-0002-00 |
| Catalog Number | 7001-0002-00 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 536959 |
| Manufacturer | COMPUMEDICS LIMITED |
| Manufacturer Address | 30-40 FLOCKHART ABBOTTSFORD, MELBOURNE AS 3067 |
| Baseline Brand Name | P-SERIES |
| Baseline Generic Name | SLEEP MONITORING SYSTEM |
| Baseline Model No | 7001-0002-00 |
| Baseline Catalog No | 7001-0002-00 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-10-06 |