MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-29 for STATIC AND DYNAMIC COMPLIANCE 22D E 777405-101 manufactured by Carefusion.
[35059674]
The carefusion identification file is (b)(4). The customer replaced the screw of the body box arm bracket with a longer screw which resolved the reported issue. The old screw was thought to be thrown away and will not be returning to carefusion for an evaluation. The device is currently working without issue. If more information becomes available a follow up will be submitted. Carefusion continues to track and trend any incident related to this issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[35059675]
The customer reported the arm of the body box became loose because the screws were too short. The arm never fell off because the staff tightened the screws 2-3 times per week. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2015-02562 |
| MDR Report Key | 5333511 |
| Date Received | 2015-12-29 |
| Date of Report | 2015-12-04 |
| Date of Event | 2015-12-04 |
| Date Mfgr Received | 2015-12-04 |
| Device Manufacturer Date | 2005-06-27 |
| Date Added to Maude | 2015-12-29 |
| 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 | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| 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 | 2015-12-29 |
| Model Number | 22D E |
| Catalog Number | 777405-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-29 |