MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-10 for VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS 29C E manufactured by Carefusion.
[38228524]
The carefusion identification file is (b)(4). This is being submitted in response to a two year retrospective complaint review that was performed by carefusion to identify following the issuance of a 483. The carefusion failure analysis lab determined that the returned device powered-up without issue, but the smell of smoke was noted. This was most likely due to a possible short circuit or burned component. Should additional information become available a supplemental report 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
[38228545]
The carefusion field service representative reported that during the install of the vmax encore module, rattling was noted. Once the device was powered-up, smoke was noted as coming from the device. The device was immediately unplugged and examined.
Patient Sequence No: 1, Text Type: D, B5
[57755837]
Device evaluation: results of investigation: the pwb assy analyzer ctrl bd untested was visually examined. Visual examination of the analyzer board, as received, confirmed the board burned due to a short circuit. The short circuit was caused by the nut that secures the board to the unit since the insulating washer that goes between the nut and the board was missing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2016-03153 |
| MDR Report Key | 5428895 |
| Date Received | 2016-02-10 |
| Date of Report | 2014-09-26 |
| Date of Event | 2014-09-26 |
| Date Mfgr Received | 2016-09-27 |
| 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 | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149227830 |
| 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 | 3 |
| Brand Name | VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2016-02-10 |
| Returned To Mfg | 2015-04-17 |
| Model Number | 29C E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 |