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 2018-11-14 for SIGNA PET/MR manufactured by Ge Medical Systems, Llc.
[127059960]
Common device name: tomographic imager combining emission computed tomography with nuclear magnetic resonance. Unique identifier: (b)(4). There are no additional device identification numbers. 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
[127059961]
It was reported that a patient underwent an mri of the internal auditory canals (iacs) to evaluate a pre-existing condition of left sided vestibular schwannoma and left side hearing loss. The patient was provided appropriate earplugs by the customer for the exam. The patient returned to the radiology department after the mri exam had been completed to report hearing loss in the right ear. The patient was evaluated by the site's audiology department where new hearing loss in the right ear was confirmed and medication was provided for treatment. The patient's condition is confirmed to have fully resolved to prior baseline.
Patient Sequence No: 1, Text Type: D, B5
[132362897]
The investigation by ge healthcare has been completed. The acoustic performance test was performed on the system and concluded that the testing meets the iec 60601-2-33 requirements and the osha levels are within the specification for this system configuration. The incident appears to be the result of human medical condition(s). The patient was provided specified hearing protection; however, a patient's medical conditions may cause sensitivity to acoustic levels that occur during normal clinical scanning. No system issue was found. No corrections are required as the system was operating within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183553-2018-00017 |
| MDR Report Key | 8068619 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-14 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-10-11 |
| Date Mfgr Received | 2018-12-17 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2018-11-14 |
| 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 | 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 | SIGNA PET/MR |
| Generic Name | SEE H10 |
| Product Code | OUO |
| Date Received | 2018-11-14 |
| 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 | 2018-11-14 |