MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,08 report with the FDA on 2001-09-28 for * 536053 manufactured by Scott Medical Products.
[21690287]
Medical graphics corp's (mgc) "qa/ra" mgr, contacted scott medical products' quality engineer to report a problem with a calibration gas standard. Based on an equipment service call at the user facility, mgc had determined that a calibration gas standard, lot no. 116617, was defective. The calibration gas standard was labeled as 21% oxygen, however it was determined to be approximately 19. 7% oxygen. Mgc was called to service the cardio2 equipment (cardiopulmonary exercise system) because the pulmonary group believed that it was not providing correct vo2 values. Smp analyzed a cylinder from the same manufacturing lot and confirmed the value of the oxygen concentration to be approx 19. 7%. Mgc completed experiments to determine the impact of using the 19. 7% oxygen calibration gas on the vo2 values. Mgc found the values of the vo2 to be approx 21% higher than the "true" value.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518435-2001-00003 |
| MDR Report Key | 353746 |
| Report Source | 05,06,07,08 |
| Date Received | 2001-09-28 |
| Date of Report | 2001-09-28 |
| Date Mfgr Received | 2001-09-21 |
| Device Manufacturer Date | 2001-06-01 |
| Date Added to Maude | 2001-10-02 |
| 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 | JACK HENNE |
| Manufacturer Street | RT 611 N |
| Manufacturer City | PLUMSTEADVILLE PA 18949 |
| Manufacturer Country | US |
| Manufacturer Postal | 18949 |
| Manufacturer Phone | 2157668861 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | CALIBRATION GAS STANDARD |
| Product Code | BXK |
| Date Received | 2001-09-28 |
| Model Number | * |
| Catalog Number | 536053 |
| Lot Number | 116617 |
| ID Number | * |
| Device Expiration Date | 2004-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 342964 |
| Manufacturer | SCOTT MEDICAL PRODUCTS |
| Manufacturer Address | ROUTE 611 N PLUMSTEADVILLE PA 18949 US |
| Baseline Brand Name | NA |
| Baseline Generic Name | CALIBRATION GAS STANDARD |
| Baseline Model No | * |
| Baseline Catalog No | 536053 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-09-28 |