MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-11-09 for OHMEDA manufactured by Ohio Medical Corporation.
[17608964]
Title: xxxxx. Event desc: during normal nasal cannula check, found no bubbling in the humidifier. Checked flowmeter, ball at liter-per-minute; when flow turned up, bubbling increased. Then tried to turn flowmeter off; ball would not decrease to zero. Found that flowmeter had small crack in the flow tube assembly. What was the original intended procedure? Na. Device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working).
Patient Sequence No: 1, Text Type: D, B5
[17704951]
The customer notified ohio medical about the problem and provided the incident report via e-mail. As the customer only provided the serial number that they (the customer) had assigned to unit, ohio medical contacted customer in an attempt to capture the serial number that the unit had been assigned by ohio medical during production. After contacting customer, ohio medical was informed that after the unit had failed, it was discarded. The customer representative communicated with the respiratory therapist who had disposed of unit in an attempt to collect more information. The respiratory therapist informed the contact that the subject unit was disposed due to its age and that the unit had been dropped prior to its failure. It is believed that the drop was the cause of the fracture in the flow tube assembly of the flowmeter. Note: (b)(6) was customer representative for the above communication narrative.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419185-2011-18268 |
| MDR Report Key | 2494113 |
| Report Source | 06 |
| Date Received | 2011-11-09 |
| Date of Report | 2011-11-29 |
| Date of Event | 2011-10-30 |
| Report Date | 2011-11-01 |
| Date Reported to FDA | 2011-11-01 |
| Date Mfgr Received | 2011-12-09 |
| Date Added to Maude | 2012-07-13 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1111 LAKESIDE DR. |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal | 60031 |
| Manufacturer Phone | 8478550500 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OHMEDA |
| Generic Name | FLOWMETER, OXYGEN |
| Product Code | CAX |
| Date Received | 2011-11-09 |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL CORPORATION |
| Manufacturer Address | 1111 LAKESIDE DR. GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-11-09 |