MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-25 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 22 777404-101 manufactured by Carefusion, Inc.
[41419862]
(b)(4). If more information becomes available a follow up will be submitted. (b)(4). The carefusion field service engineer (fse) was onsite and stated the arm was tight so when the customer adjusted the arm, it probably put pressure and loosened the screw. The fse tightened the arm and lubricated the joints which solved the reported issue. The fse repaired the impulse oscillatory spirometry (ios) arm and was returned to the customer. The device is currently working without issue.
Patient Sequence No: 1, Text Type: N, H10
[41419863]
The customer reported the impulse oscillatory spirometry (ios) arm fell off. There was no patient involvement associated with this event. The carefusion field service engineer (fse) was scheduled to inspect the unit at the customer's facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2016-03378 |
| MDR Report Key | 5527757 |
| Date Received | 2016-03-25 |
| Date of Report | 2016-02-29 |
| Date of Event | 2016-02-29 |
| Date Mfgr Received | 2016-02-29 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2016-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 Phone | 8473628056 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 1100 BIRD CENTER DR. |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92262 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STATIC AND DYNAMIC COMPLIANCE |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2016-03-25 |
| Model Number | VMAX ENCORE 22 |
| Catalog Number | 777404-101 |
| 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 | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-25 |