MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-07-16 for PROSOUND F75 ULTRASOUND SCANNER manufactured by Hitachi Aloka Medical, Ltd.
[4627118]
Device: prosound f75 ultrasound scanner (k123828) - possibility that a gel threadlocker coating has not been added to the screws which hold the arm together, resulting in instability or loose monitor arm. To date this issue has not affected any patients or caused any physical harm. Review of all affected manufacturing serial numbers sold in the united states for service and complaint identified one complaint of "loose monitor arm". This service/complaint record number: (b)(4) is dated 12/10/2013. The service person tightened the loose screws in the monitor arm and corrected the problem without further issue. There is no complaint of injury, adverse event, or repeated complaints of loosened monitor arm associated with this customer since servicing the device in december. This report is to notify the fda of an assembly issue and corrective action to replace all affected serial numbers with a new monitor arm. Affected serial numbers: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12058983]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610865-2014-00001 |
| MDR Report Key | 3963714 |
| Report Source | 07 |
| Date Received | 2014-07-16 |
| Date of Report | 2014-06-26 |
| Date of Event | 2014-06-11 |
| Date Facility Aware | 2014-06-11 |
| Report Date | 2014-06-26 |
| Date Added to Maude | 2014-08-06 |
| 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 Street | 6-22-1, MURE, MITAKA-SHI |
| Manufacturer City | TOKYO |
| Manufacturer Country | JA |
| Manufacturer City | TOKYO |
| Manufacturer Country | JA |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSOUND F75 ULTRASOUND SCANNER |
| Generic Name | PROSOUND F75 |
| Product Code | GXX |
| Date Received | 2014-07-16 |
| Model Number | F75 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HITACHI ALOKA MEDICAL, LTD |
| Manufacturer Address | 6-22-1, MURE, MITAKA-SHI TOKYO 181-8622 JA 181-8622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-16 |