MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-06-03 for PRECISION MEDICAL INC UNK manufactured by Precision Medical, Inc..
[3547108]
A fire erupted in the victims travel camper killing him, allegedly due to the use of a space heater and devices used to supply oxygen (oxygen tanks, regulators, conserving devices, and concentrators).
Patient Sequence No: 1, Text Type: D, B5
[10783875]
Being sent for eval (b)(4). The law suit states that a precision medical conserver was involved in this incident, but no evidence has come forward. Unclear as to what device, the serial number or the date of mfr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523148-2013-00002 |
| MDR Report Key | 3158750 |
| Report Source | 07 |
| Date Received | 2013-06-03 |
| Date of Report | 2013-06-03 |
| Date of Event | 2012-02-21 |
| Date Mfgr Received | 2013-02-28 |
| Date Added to Maude | 2013-06-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM PARKER |
| Manufacturer Street | 300 HELD DR. |
| Manufacturer City | NORTHAMPTON PA 18067 |
| Manufacturer Country | US |
| Manufacturer Postal | 18067 |
| Manufacturer Phone | 6102626090 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISION MEDICAL INC |
| Generic Name | CONSERVER ? |
| Product Code | NFB |
| Date Received | 2013-06-03 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL, INC. |
| Manufacturer Address | 300 HELD DR. NORTHAMPTON PA 18067 US 18067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2013-06-03 |