MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-12-18 for EZ-OX PLUS NA manufactured by Air Liquide Healthcare America.
[18182949]
(b)(6) from (b)(6) hospital in (b)(6) informed air liquide healthcare america an incident had occurred involving an ez-ox plus device, which is a portable oxygen delivery system containing oxygen usp. Air liquide healthcare america contacted (b)(6) to discuss the incident and the following info was acquired: a pt suffered cardiopulmonary arrest and the resuscitation cart containing an ez-ox plus was brought to the pt. When connecting the manual resuscitation bag to the ez-ox plus container, hospital personnel attached the tubing to the container's diss connection instead of the device's barb connection. The ez-ox plus flowmeter was set at 10-liters per minute and resuscitation efforts proceeded. After a few mins hospital personnel noticed the oxygen tubing was not connected to the device's barb connection. After a period of time, the resuscitation stopped because the pt had expired. The ez-ox plus device was quarantined by the director of respiratory therapy.
Patient Sequence No: 1, Text Type: D, B5
[18202534]
During the conversation between (b)(6) and (b)(6), she stated that she felt the event did not contribute to the death of the pt. After the incident, air liquide healthcare america conducted an evaluation of the ez-ox plus design and concluded that there is a very low risk of reoccurrence. First, the device's product label contains clear instructions to connect the oxygen supply tube to the hose barb and there is only one hose barb on the device. Second, the hose barb connection and the diss connection use different fittings. The hose barb connection is the standard slip-on hose barb commonly found on hospital respiratory therapy equipment. The diss connection is a larger and differently configured threaded connection. Third, the diss connection is permanently labeled as "diss connection at 40 lpm". The investigation determined that the incident was a result of human error during a high stress situation. (b)(4). This is the only adverse event report received by air liquide healthcare america concerning this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628496-2007-00001 |
| MDR Report Key | 2142453 |
| Report Source | 05,06 |
| Date Received | 2007-12-18 |
| Date of Report | 2007-12-13 |
| Date of Event | 2007-11-30 |
| Date Mfgr Received | 2007-11-30 |
| Date Added to Maude | 2011-06-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | WRAY LAFOND |
| Manufacturer Street | 12800 W. LITTLE YORK ROAD |
| Manufacturer City | HOUSTON TX 770414218 |
| Manufacturer Country | US |
| Manufacturer Postal | 770414218 |
| Manufacturer Phone | 7138962281 |
| Manufacturer G1 | AIR LIQUIDE HEALTHCARE USA |
| Manufacturer Street | 27 FORESTWOOD COURT UNIT B |
| Manufacturer City | ROMEOVILLE IL 60446 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60446 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZ-OX PLUS |
| Generic Name | PORTABLE OXYGEN DELIVERY SYSTEM |
| Product Code | ECX |
| Date Received | 2007-12-18 |
| Model Number | EZ-OX PLUS |
| Catalog Number | NA |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIR LIQUIDE HEALTHCARE AMERICA |
| Manufacturer Address | ROMEOVILLE IL 60446 US 60446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-12-18 |