MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-28 for GE 1.5T SIGNA HDX MR SYSTEM manufactured by Ge Medical Systems, Llc.
[176681311]
Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[176681312]
It was reported via medwatch report # mw5091794, that following an mr exam of the shoulder, a patient complained of an acoustic injury. The patient was evaluated by an ent physician three weeks after the mr exam and was diagnosed with tinnitus and hyperacusis. The patient was prescribed oral steroids which did not resolve the acoustic injury. The patient was provided the alert bulb during the exam, however, the patient never utilized the alert or informed the technologist of any acoustic discomfort or concerns throughout the duration of the exam. The patient was provided headphones with an nrr of 30 which meets ge healthcare's requirements for hearing protection, but the patient stated that they were loose fitting and did not completely cover both ears.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183553-2020-00003 |
| MDR Report Key | 9638844 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-28 |
| Date of Report | 2020-03-10 |
| Date of Event | 2019-09-18 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2020-01-28 |
| 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 | JACQUI BUDDE |
| Manufacturer Street | 3200 N. GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE 1.5T SIGNA HDX MR SYSTEM |
| Generic Name | NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2020-01-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 3200 N GRANDVIEW BLVD. WAUKESHA, WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-28 |