MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-17 for PRECISION MEDICAL FLOW METER 2MFA1001 2MFA 1001 manufactured by Precision Medical Inc..
[1917611]
Title: xxxxx. Event desc: nurse noticed something was not right with the flow meter and asked the charge nurse to check the flow meter. The pt was on an oxygen face mask connected to the flow meter involved in the incident. As the charge nurse entered the room, she noticed that it smelled like something was burning. She observed that the flow tube was black. She had respiratory therapy paged to come to the room. She then began to turn down the flow meter, as she was adjusting the flow meter, it exploded and flames began to shoot out of the wall. A code red was initiated via the phone. The pt was immediately evacuated from the room and the door to the room was closed. The nursing supervisor turned off the oxygen to half of the unit. Security extinguished the burning pieces. There was no pt harm, employee injury or damage to the facility.
Patient Sequence No: 1, Text Type: D, B5
[9162746]
Notified by hospital that there had been a fire incident with a flow meter in the icu ward on (b)(6) 2011. Notified by hospital on (b)(6) 2011. Visited hospital on (b)(6) 2011. Fire occurred in the icu ward, with a 2mfa flow meter. Flow meter had been operating at 10 liters per minute for several days. Fire occurred in flow meter. Cause is unk, at this time. Flow meter was sent to an outside agency (ecri) for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523148-2011-00001 |
| MDR Report Key | 2026586 |
| Report Source | 06 |
| Date Received | 2011-03-17 |
| Date of Report | 2011-03-01 |
| Date of Event | 2011-02-24 |
| Date Mfgr Received | 2011-03-01 |
| Device Manufacturer Date | 1995-05-01 |
| Date Added to Maude | 2012-06-05 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISION MEDICAL FLOW METER |
| Generic Name | OXYGEN FLOW METER |
| Product Code | CAX |
| Date Received | 2011-03-17 |
| Model Number | 2MFA1001 |
| Catalog Number | 2MFA 1001 |
| Lot Number | 5/95 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-03-17 |