MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-07-25 for SENSORMEDICS VMAX 229 769200-101 manufactured by Cardinal Health 207, Inc..
[883829]
The following descriptions of the event were documented by a cardinal health tech support specialist in response to two phone conversations with a user facility representative. On [2008] "[name removed] needs a policy on the disposal of the gas tanks [cylinders] from cardinal health. Will e-mail this customer a document that gives the customer instructions on how to dispose of the gas tanks [cylinders] cardinal health sells to its customers, and this document is intended as a guideline only. As for a policy cardinal health does not have a policy in place for customers on the disposal of gas tanks [cylinders]. They will need to follow local city and state ordinance on the disposal of the gas tanks [cylinders]. " on [06/26/2008] "spoke to [name removed] and i discovered the reason he called to inquire on the policy for the disposal of the gas tanks [cylinders] is that he sated one of the employees at that facility has possibly be injured by trying to break off the valve stem of the gas tank [cylinder] so they could dispose of that tank [cylinder]. He would not go into detail on that issue, however he stated that they are in need of obtaining any written policy cardinal health puts forth on how to dispose of the gas tanks [cylinders] that customers purchase. I advised this customer that i would research that question for him and follow up with our regulatory dept for direction on that issue. "
Patient Sequence No: 1, Text Type: D, B5
[7888174]
On june 27, 2008, cardinal health sent a certified letter to the user facility seeking additional information concerning the reported event to include any information pertaining to the type of injury the user facility's employee may have suffered and the type of treatment required. As of july 24, 2008 the user facility had not responded to the letter, thus cardinal health sent a follow-up request via e-mail. The user facility responded to cardinal health's e-mail request with the following statement and did not provide any additional information concerning the reported event to include any information pertaining to the type of injury the user facility's employee may have suffered and the type of treatment required. "thank you for your attention to this matter. But promptly after this incident in question, we developed an internal policy for the disposal of cal tanks from cardinal. From my standpoint, there will be no further need of your support to resolving this matter. " the user facility did not submit a user facility report to the manufacturer. Based on the information documented by the cardinal health tech support specialist in response to the phone conversations with a user facility representative, cardinal health has determined that there was no failure of the device and that the event was caused by an employee of the user facility trying to break the stem off of the gas cylinder contrary to the cardinal health guidelines on recycling or disposal of gas cylinders.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2008-00063 |
| MDR Report Key | 1082237 |
| Report Source | 06 |
| Date Received | 2008-07-25 |
| Date of Report | 2008-07-25 |
| Date of Event | 2008-06-18 |
| Report Date | 2008-06-18 |
| Date Mfgr Received | 2008-06-26 |
| Device Manufacturer Date | 2001-02-13 |
| Date Added to Maude | 2009-02-09 |
| 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 | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES STYTLE |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal | 92262 |
| Manufacturer Phone | 7608837120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSORMEDICS |
| Generic Name | PULMONARY/METABOLIC SYSTEMS |
| Product Code | BZC |
| Date Received | 2008-07-25 |
| Model Number | VMAX 229 |
| Catalog Number | 769200-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 207, INC. |
| Manufacturer Address | 1100 BIRD CENTER DRIVE PALM SPRINGS CA 92262 US 92262 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-07-25 |