MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-07-22 for * 1801 manufactured by Ipi Medical.
[121253]
Thermometer does not read the correct temperature.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417519-1998-00005 |
| MDR Report Key | 178888 |
| Report Source | 05 |
| Date Received | 1998-07-22 |
| Date of Report | 1998-07-20 |
| Date Mfgr Received | 1998-06-17 |
| Date Added to Maude | 1998-07-28 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | VENTILATOR CIRCUIT THERMOMETER CONNECTOR |
| Product Code | FLK |
| Date Received | 1998-07-22 |
| Model Number | * |
| Catalog Number | 1801 |
| 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 | 173939 |
| Manufacturer | IPI MEDICAL |
| Manufacturer Address | 3217 N. KILPATRICK CHICAGO IL 60641 US |
| Baseline Brand Name | NA |
| Baseline Generic Name | VENTILATOR CIRCUIT THERMOMETER CONNECTOR |
| Baseline Model No | * |
| Baseline Catalog No | 1801 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-07-22 |