MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-09-16 for STATIC AND DYNAMIC COMPLIANCE 62 JAEGER 773835-101 manufactured by Carefusion, Inc.
[54925846]
(b)(4). A replacement arm assembly was sent to the customer to resolve the issue. The customer stated no parts will be returned, therefore no investigation can be performed.
Patient Sequence No: 1, Text Type: N, H10
[54925847]
The customer reported while using the static and dynamic compliance; the arm inside the body box broke due to the patient momentarily passed out during the procedure. The customer reported the patient slid from the seat while holding the arm inside the body box thus breaking it. The customer stated the device was used on a patient for pulmonary function testing at the time of the event. However, there was no patient impact associated with this event. There was no allegation of the unit or arm malfunctioning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2016-04452 |
| MDR Report Key | 5956422 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-09-16 |
| Date of Report | 2016-09-01 |
| Date of Event | 2016-09-01 |
| Date Mfgr Received | 2016-09-08 |
| Device Manufacturer Date | 2010-06-01 |
| Date Added to Maude | 2016-09-16 |
| 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 Phone | 7149227830 |
| 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 | 3 |
| Brand Name | STATIC AND DYNAMIC COMPLIANCE |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2016-09-16 |
| Model Number | 62 JAEGER |
| Catalog Number | 773835-101 |
| Lot Number | SMI002762-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Other | 2016-09-16 |