MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-01-23 for PRECISION MEDICAL INC. FLOW METER 2MFA1001 manufactured by Precision Medical Inc..
[19687331]
Flow meter exploded breaking flow tube. Flow meter was in a unoccupied room, in the off position when the flow tube broke for no apparent reason. No property damage, and no one was injured.
Patient Sequence No: 1, Text Type: D, B5
[19838906]
This device is being sent to precision medical for evaluation. Under returned authorization number (b)(4) not received as of (b)(4)2013. The flow meter was returned to precision medical inc on (b)(4) 2013. As found description: the outside housing is broken, with pieces missing, the flow tube itself is missing. The body appears to be whole. The housing has turned yellow from age. The flow meter is 16 years old, with a life expectancy of 10 years. Probable cause of housing failure, was a weakness caused by stress of damage or age. Conclusion: would recommend replacing all flow meters older than ten years of age, or at least an inspection of all flow meters, for damage or aging.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523148-2013-00001 |
| MDR Report Key | 2977786 |
| Report Source | 07 |
| Date Received | 2013-01-23 |
| Date of Report | 2013-01-11 |
| Date of Event | 2013-01-10 |
| Date Facility Aware | 2013-01-10 |
| Report Date | 2013-01-11 |
| Date Reported to FDA | 2013-01-11 |
| Date Reported to Mfgr | 2013-01-11 |
| Date Mfgr Received | 2013-01-10 |
| Device Manufacturer Date | 1997-03-01 |
| Date Added to Maude | 2013-04-15 |
| 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 |
| 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 | 3 |
| Brand Name | PRECISION MEDICAL INC. FLOW METER |
| Generic Name | OXYGEN FLOW METER |
| Product Code | CAX |
| Date Received | 2013-01-23 |
| Returned To Mfg | 2013-01-10 |
| Model Number | 2MFA1001 |
| Catalog Number | 2MFA1001 |
| Lot Number | 0397 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 16 YR |
| 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 | 2013-01-23 |