MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-10-05 for PRECISION MEDICAL INC. FLOW METER PM5200M manufactured by Precision Medical, Inc..
[28352239]
Blender was being used in a hospital, hand sanitizer was being used in the area that contained ethanol. "sterillium viruguard". There was an explosion where the flow meter attached to the blender exploded. Conclusion: unk cause of failure, device not returned for investigation. Warnings in ifu state to keep away from flammable and explosive gases. No other complaints of this exist for precision medical blenders.
Patient Sequence No: 1, Text Type: N, H10
[28352240]
The 30 liter flow tube of an oxygen blender exploded, in an area where hand sanitizer was being used. There was no personal injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523148-2015-00003 |
| MDR Report Key | 5147816 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-10-05 |
| Date of Report | 2015-10-05 |
| Date of Event | 2015-08-07 |
| Date Facility Aware | 2015-08-07 |
| Report Date | 2015-10-05 |
| Date Reported to Mfgr | 2015-09-28 |
| Date Mfgr Received | 2015-09-28 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2015-10-14 |
| 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 | RISK MANAGER |
| 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 | 0 |
| Brand Name | PRECISION MEDICAL INC. FLOW METER |
| Generic Name | OXYGEN BLENDER |
| Product Code | CAX |
| Date Received | 2015-10-05 |
| Model Number | PM5200M |
| Catalog Number | PM5200M |
| 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 | 1. Other | 2015-10-05 |