MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2011-04-11 for MTD4000 manufactured by Zmi Electronics, Ltd..
[2230178]
Physician used device to treat a pt with neck protocol at (b)(6). Force, rest 15 seconds, (b)(6) hold for 30 seconds for total treatment time of 10 minutes. The device over-pulled and allegedly caused neck injury. Pressing nurse call button and stop button allegedly did not work. Device was turned off by turning off the main power switch. (b)(4) received an email notice from (b)(6) that was a forwarded letter from dr. (b)(6) of (b)(6) in (b)(6). In the email, dr. (b)(6) wrote that her female patient was on the table for decompression of her neck when the traction head pulled and pulled - not event stopping when they pressed stop. The machine only stopped when they turned the machine off with the back power switch. Later i was informed from (b)(4) that the pt kill switch and stop button did not work. He also told me that the device was pulling at approx (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[9377735]
When (b)(4) received the device, we opened it and noticed that the cable had slipped off the pulley and that there were pieces of plastic, torn off the cable, inside the unit. After taking pictures and sending them to (b)(4), (b)(4) closed the unit and returned the unit to (b)(4), for them to evaluate. The unit was returned to (b)(4) on (b)(4) 2011 and is currently in (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617486-2011-00001 |
| MDR Report Key | 2321259 |
| Report Source | 07,08 |
| Date Received | 2011-04-11 |
| Date of Report | 2011-04-07 |
| Date of Event | 2011-01-01 |
| Date Facility Aware | 2011-03-11 |
| Report Date | 2011-04-09 |
| Date Reported to FDA | 2011-04-11 |
| Date Reported to Mfgr | 2011-04-11 |
| Date Mfgr Received | 2011-03-11 |
| Device Manufacturer Date | 2010-07-01 |
| Date Added to Maude | 2011-11-04 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. YUTA LEE |
| Manufacturer Street | 6F-1, NO. 286-4, SHIN YA RD |
| Manufacturer City | KAOHSIUNG 806 |
| Manufacturer Country | TW |
| Manufacturer Postal | 806 |
| Manufacturer Phone | 9191404 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTD4000 |
| Generic Name | TRACTION DEVICE |
| Product Code | ITH |
| Date Received | 2011-04-11 |
| Returned To Mfg | 2011-03-30 |
| Model Number | MTD4000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZMI ELECTRONICS, LTD. |
| Manufacturer Address | 6F-1, NO. 286-4, SHIN YA RD KAOHSIUNG TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-04-11 |