MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-12 for ACHIEVA Y ACHIEVA PS manufactured by Puritan Bennett.
[2289881]
While in (b)(6), achieva ventilator external and internal batteries holding no charge. Approx 45 mins of time combined. Client manually operated until arrival at (b)(6), plugged into ac outlet at center. Client's father contacted, dme to replace ventilator and external battery. Father brought charged external battery to center. Cargo external battery in use since (b)(6) 2009.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022650 |
| MDR Report Key | 2299722 |
| Date Received | 2011-10-12 |
| Date of Report | 2011-10-04 |
| Date of Event | 2011-10-04 |
| Date Added to Maude | 2011-10-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACHIEVA |
| Generic Name | VENTILATOR |
| Product Code | CBK |
| Date Received | 2011-10-12 |
| Returned To Mfg | 2011-10-04 |
| Model Number | Y ACHIEVA PS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PURITAN BENNETT |
| Brand Name | CARGO EXTERNAL BATTERY |
| Generic Name | BATTERY |
| Product Code | FCO |
| Date Received | 2011-10-12 |
| Returned To Mfg | 2011-10-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | PURITAN BENNETT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-10-12 |