MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-14 for MEDGRAPHICS 1085-D manufactured by Medgraphics.
[108107]
In 2/97, three medgraphics 1085 advantage plus systems were purchased by medical center to replace the older 1070 models. In 6/97, it was noted that the 1085 was producing comparative diffusion readings 5-10% lower than the 1070. In 11/97, g. C. Columns were replaced in the three 1085 units. The 1085 units continued to produce results that were lower than the 1070 beyond the acceptable variation (6%).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 148756 |
| MDR Report Key | 148756 |
| Date Received | 1998-01-14 |
| Date of Report | 1997-12-18 |
| Date Facility Aware | 1997-11-01 |
| Report Date | 1997-12-18 |
| Date Reported to Mfgr | 1997-12-18 |
| Date Added to Maude | 1998-02-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDGRAPHICS |
| Generic Name | BODY PLETHYSMOGRAPH WITH DIFFUSING CAPACITY |
| Product Code | CCM |
| Date Received | 1998-01-14 |
| Model Number | 1085-D |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 144960 |
| Manufacturer | MEDGRAPHICS |
| Manufacturer Address | 350 OAK GROVE PKWY ST. PAUL MN 55127 US |
| Brand Name | MEDGRAPHICS |
| Generic Name | BODY PLETHYSMOGRAPH WITH DIFFUSING CAPACITY |
| Product Code | CCM |
| Date Received | 1998-01-14 |
| Model Number | 1085-D |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 2 |
| Device Event Key | 144961 |
| Manufacturer | MEDGRAPHICS |
| Manufacturer Address | 350 OAK GROVE PKWY ST. PAUL MN 55127 US |
| Brand Name | MEDGRAPHICS |
| Generic Name | BODY PLETHYSMOGRAPH WITH DIFFUSING CAPACITY |
| Product Code | CCM |
| Date Received | 1998-01-14 |
| Model Number | 1085-D |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 3 |
| Device Event Key | 144964 |
| Manufacturer | MEDGRAPHICS |
| Manufacturer Address | 350 OAK GROVE PKWY ST. PAUL MN 55127 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-01-14 |