MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-08 for HIGH FLOW INSUFFLATION UNIT UHI-4 manufactured by Olympus Medical Systems Corp..
[74832610]
The subject device was returned to olympus medical systems corp. (omsc) for evaluation. Omsc repeated the cycle 100 times which consists of turn-on and turn-off, but the phenomenon was not reproduced. Omsc insufflated to the model simulating the human body for 3 hours, but the phenomenon was not reproduced. Omsc will continue the investigation about this event.
Patient Sequence No: 1, Text Type: N, H10
[74832611]
During ldg, the subject uhi-4 was turned off suddenly. The user tried to reboot the subject uhi-4, but the phenomenon occurred three to four times. The user replaced the subject device with a spare device, and completed the procedure. There was no report of the patient? S injury regarding this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-00549 |
| MDR Report Key | 6550916 |
| Date Received | 2017-05-08 |
| Date of Report | 2017-08-09 |
| Date of Event | 2017-04-12 |
| Date Mfgr Received | 2017-07-21 |
| Device Manufacturer Date | 2012-05-10 |
| Date Added to Maude | 2017-05-08 |
| 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 KATSUAKI MORITA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO |
| Manufacturer Country | US |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HIGH FLOW INSUFFLATION UNIT |
| Generic Name | HIGH FLOW INSUFFLATION UNIT |
| Product Code | FCX |
| Date Received | 2017-05-08 |
| Returned To Mfg | 2017-04-26 |
| Model Number | UHI-4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-08 |