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 2017-04-27 for SIGNA PET/MR manufactured by Ge Medical Systems, Llc.
[73860832]
There are no additional device identification numbers. Tomographic imager combining emission computed tomography with nuclear magnetic resonance 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
[73860833]
It was initially reported that a patient, who was wearing ear plugs, complained of not being able to hear after a mri exam. The patient was sent to the site's nursing station for care, however no details were provided that the patient required or received medical treatment. The site followed up the following day and the patient said that it had improved but not fully. The customer later confirmed that the patient had mild sensorineural hearing loss at 2 khz in the right ear. Baseline hearing was not known.
Patient Sequence No: 1, Text Type: D, B5
[96885588]
The investigation by ge healthcare has been completed. Acoustic measurements were performed on the pet/mr system and based on the testing completed, it was concluded that the pet/mr system met the (b)(4) requirements and osha levels. The system was operating within the regulatory limits. System logs were reviewed and no unusual errors that may have indicated gradient subsystem failures or other contributing factors to potential high acoustic noise were identified. The likely primary root cause of this event is a patient medical condition that caused sensitivity to acoustic levels. No systemic product issue was identified. However, due to the additional engineering investigation that was performed, the customer? S gradient coil was replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183553-2017-00006 |
| MDR Report Key | 6527096 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-27 |
| Date of Report | 2017-07-18 |
| Date of Event | 2016-01-20 |
| Date Mfgr Received | 2017-07-14 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2017-04-27 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | TOMOGRAPHIC IMAGER COMBINING |
| Product Code | OUO |
| Date Received | 2017-04-27 |
| ID Number | NOT APPLICABLE |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-27 |