MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-03 for MASTERSCREEN BODY MS-BODY/DIFF SES 30336-001 manufactured by Carefusion, Inc.
[63803175]
(b)(4). A carefusion field service representative (fsr) went onsite to evaluate the device. The fsr determined that the device had a defective demand valve and the component was replaced. After the repair, the demand valve was not available for return to the manufacturer. At this time, the customer has not responded to requests for additional information regarding this event. If additional information becomes available, it will be submitted in a follow up report.
Patient Sequence No: 1, Text Type: N, H10
[63803176]
The customer reported while performing a lung diffusion carbon monoxide (dlco) test the demand valve is continuously blowing during the patient's efforts and the patient complained, "it hurt her lungs". There was no further information regarding patient harm or injury with the reported issue, it is currently unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2017-05167 |
| MDR Report Key | 6220679 |
| Date Received | 2017-01-03 |
| Date of Report | 2017-01-03 |
| Date of Event | 2016-12-05 |
| Date Mfgr Received | 2016-12-05 |
| Device Manufacturer Date | 2016-04-01 |
| Date Added to Maude | 2017-01-03 |
| 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 | 3 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | LIEBNIZSTRASSE 7 |
| Manufacturer City | HOECHBERG |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MASTERSCREEN BODY |
| Generic Name | PLETHYSMOGRAPH, VOLUME |
| Product Code | JEH |
| Date Received | 2017-01-03 |
| Model Number | MS-BODY/DIFF SES |
| Catalog Number | 30336-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | LIEBNIZSTRASSE 7 HOECHBERG GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-03 |