MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a unknown report with the FDA on 2015-09-14 for H140-10-5 manufactured by .
[26735734]
The scale could not be evaluated. It was not returned. The user has been contacted requesting additional info on location of scale. To date scale has not been located. There was no report of injury. The malfunction reported would not contribute to a death or serious injury.
Patient Sequence No: 1, Text Type: N, H10
[26735735]
Title: xxxxx. Event desc: pt weighed before surgery. Pt's wool sweater touched the metal height bar. The rice lake standing scale made a loud spark and had some white smoke. Then the rice lake standing scale turned off. When the nurse turned it back on it had lines "slop". The pt did not sustain any injury. What was original intended procedure? Weigh pt before surgery. Device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000122543-2015-00001 |
| MDR Report Key | 5098023 |
| Report Source | UNKNOWN |
| Date Received | 2015-09-14 |
| Date of Report | 2015-06-24 |
| Date of Event | 2015-02-20 |
| Report Date | 2015-06-01 |
| Date Reported to FDA | 2015-06-01 |
| Date Mfgr Received | 2015-08-25 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2015-09-23 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 230 WEST COLEMAN STREET |
| Manufacturer City | RICE LAKE WI 54868 |
| Manufacturer Country | US |
| Manufacturer Postal | 54868 |
| Manufacturer Phone | 7152349171 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Product Code | FRI |
| Date Received | 2015-09-14 |
| Model Number | H140-10-5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-14 |