MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-03-08 for PRECISION MEDICAL PM1000 manufactured by Precision Medical, Inc..
[1335866]
Flow selector is mislabeled. Selector can be positioned in the "on" position to administer oxygen and really be in the "off" position.
Patient Sequence No: 1, Text Type: D, B5
[8455962]
Additional lot #: 0110. Found that device is mislabeled on two different lots 12/09 and 01/10. Device can appear to be in the on position when it is really off.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523148-2010-00001 |
| MDR Report Key | 1627422 |
| Report Source | 07 |
| Date Received | 2010-03-08 |
| Date of Report | 2010-03-05 |
| Date of Event | 2010-03-05 |
| Date Mfgr Received | 2010-03-02 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2010-03-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JIM PARKER, MANAGER |
| Manufacturer Street | 300 HELD DR. |
| Manufacturer City | NORTHAMPTON PA 18067 |
| Manufacturer Country | US |
| Manufacturer Postal | 18067 |
| Manufacturer Phone | 6102626090 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISION MEDICAL |
| Generic Name | OXYGEN FLOW SELECTOR |
| Product Code | BXY |
| Date Received | 2010-03-08 |
| Model Number | PM1000 |
| Catalog Number | PM1000 |
| Lot Number | 1209 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL, INC. |
| Manufacturer Address | 30 HELD DR. NORTHAMPTON PA 18067 US 18067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2010-03-08 |