MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-10 for STATIC AND DYNAMIC COMPLIANCE 22 E 777404-101 manufactured by Carefusion.
[38158015]
This mdr is being submitted in response to a two year retrospective complaint review that was performed by carefusion to identify mdrs following the issuance of a 483. The carefusion (b)(4). The printer was evaluated by a carefusion failure analysis technician. On visual inspection there was no burnt markings or smell noted. The device was unable to be powered on due to a short circuit as evidenced by the customer's report of smoke coming from the back of the printer. It was determined that the device has reached it's end of life and will be scrapped. A replacement printer was sent to the customer. 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
[38158016]
The customer reported seeing smoke come from the rear of the printer when it was turned on and is now non-operational. There was no visual damage to the device and there was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2016-03148 |
| MDR Report Key | 5428604 |
| Date Received | 2016-02-10 |
| Date of Report | 2015-01-19 |
| Date of Event | 2015-01-19 |
| Date Mfgr Received | 2015-01-29 |
| Date Added to Maude | 2016-02-10 |
| 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 | 2016-02-10 |
| Returned To Mfg | 2015-01-29 |
| Model Number | 22 E |
| Catalog Number | 777404-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-02-10 |