MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-06-07 for MIST THERAPY SYSTEM 5.0 CP-80000 manufactured by Celleration, Inc..
[662671]
Physical therapist (pt) said she felt a sensation in her arm, like a wave or current, starting around her forearm and up to her shoulder. She said she didn't connect the sensation with the use of the mist system until she started a treatment on another pt, and the sensation happened again when she turned the transducer button power on. She said she was holding the transducer without leaning her arm on anything, horizontally, with her one hand firmly around the center of the transducer, not touching either the transducer cord connection or the power button. When she turned the transducer power button off, the "current" stopped. She said she was wearing no jewelry on that arm, saw no alarms on the he mist system, and that the unit appeared to be operating normally. She had used that unit many times before, as had other pts in her dept. No one else had experienced the sensation. They discontinued use of this system once she reported the problem to her supervisor in the department. They did not try to recreate the problem on site. They have all used the other mist therapy unit at their site since, with no recurrence of this sensation.
Patient Sequence No: 1, Text Type: D, B5
[7979370]
As of the date of this report, the device has not yet been returned to the mfr for analysis. Should the device be returned, failure analysis will be performed by the mfr and a supplemental report filed at that time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004580659-2007-00001 |
| MDR Report Key | 863141 |
| Report Source | 05 |
| Date Received | 2007-06-07 |
| Date of Report | 2007-06-07 |
| Date of Event | 2007-05-10 |
| Date Mfgr Received | 2007-05-10 |
| Device Manufacturer Date | 2004-06-01 |
| Date Added to Maude | 2008-02-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHY SIMPSON |
| Manufacturer Street | 10250 VALLEY VIEW ROAD SUITE 137 |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal | 55344 |
| Manufacturer Phone | 9522248700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIST THERAPY SYSTEM 5.0 |
| Generic Name | UNK |
| Product Code | NRB |
| Date Received | 2007-06-07 |
| Catalog Number | CP-80000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 966973 |
| Manufacturer | CELLERATION, INC. |
| Manufacturer Address | EDEN PRAIRIE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-07 |