MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-03-15 for TRACKMASTER TREADMILL PEDIATRIC 776112-101 manufactured by Carefusion.
[1957129]
The following descriptions of the event were copied from e-mails from a carefusion clinical specialist, carefusion sales rep and documented by a carefusion tech support specialist in response to a phone conversation with user facility rep. "a child fell on the treadmill, tech switched it off with emergency red button, they said they lost all the egg. I can't see how this could happen. This is an incident and they are having meeting about it. Any idea? " "the child fell on his own, and then they hit the emergency stop button. It is possible that things weren't shut down correctly. " "what happened was that the child coded on the treadmill and ended up in the icu. This child did not recover. When he began to fall and arrest, the tech hit the red emergency shut off button on the treadmill. The cardiosoft program had a message that said the test ended and there was no data for them to review to see the rhythm the child was in afterwards. They were able to interrogate his pacemaker to find out what happened and this was lucky. They are writing up an incident report and having a medical review of this because they feel that they could be held liable if they can't prove that they were testing a pt safely due to lost data. " "[name removed] provided below info: it was not a child. It was an adult who fell off the tm [treadmill]. Pt had a history of heart condition. Pt expired a couple of days later in icu. [name removed] couldn't remember what actually happened during the incident since it was very hectic situation. She remembers using emergency button to stop the test, but couldn't remember if she has saved the full disclosure or not. She did print out the test result during the course of the test. Pt had a pacemaker and they were able to interrogate the pacemaker to retrieve the pt's heart condition. Since pt expired, she was not able to provide any more info. I did ask if the tm [treadmill] had anything to do with the pt's fall and she said "no, it was his heart condition". However, [name removed] explained that they are still having the same issue with tm [treadmill] not inclining during the test unless it is reset by either hard reset (turn off/on or use emergency sw). As long as she resets the tm [treadmill] before each test, everything is fine. Informed [name removed] that i will further research with full vision for correction. She appreciated the f/u and asked for my full name and contact info. I provided my contact info. Will research further for the tm [treadmill] correction with full vision and will get back to (b)(6) and/or possible dispatch svc call if part needs replacement. "
Patient Sequence No: 1, Text Type: D, B5
[9222466]
The user facility did not submit a user facility report to the mfr. Event codes were derived based on info provided by the user facility via interaction with a carefusion clinical specialist, a carefusion sales rep and a carefusion tech support specialist. (b)(4) not inclining during test. Carefusion has made arrangements with the user facility to have a carefusion field service rep come on site and evaluate the device. Once the eval of the device is complete, carefusion will submit a f/u medwatch report. At present, carefusion considers this to be an isolated incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2011-00018 |
| MDR Report Key | 2029134 |
| Report Source | 06,07 |
| Date Received | 2011-03-15 |
| Date of Report | 2011-02-15 |
| Date of Event | 2011-02-15 |
| Date Facility Aware | 2011-02-15 |
| Device Manufacturer Date | 2004-03-01 |
| Date Added to Maude | 2011-03-25 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | JAMES STYTLE |
| Manufacturer Phone | 7608837120 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer Street | 1100 BIRD CENTER DR. |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92262 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRACKMASTER |
| Generic Name | TREADMILL, POWERED / IOL |
| Product Code | IOL |
| Date Received | 2011-03-15 |
| Model Number | TREADMILL PEDIATRIC |
| Catalog Number | 776112-101 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | YORBA LINDA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-03-15 |