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 2017-01-09 for SIGNA PETMR manufactured by Ge Medical Systems, Llc.
[64206552]
Ge healthcare? S investigation in 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
[64206553]
It was reported that a patient undergoing a petmr exam complained of right ear pain and hearing loss. The hearing loss was later confirmed by a physician.
Patient Sequence No: 1, Text Type: D, B5
[65851739]
The investigation by ge healthcare has been completed. The signa pet/mr system limits acoustic noise, when hearing protection is used. The system operator is responsible for providing the hearing protection. In this case, hearing protection was provided and placed by the patient. The system acoustic level was tested to meet local regulations. No systemic issue was found. No corrections are required as the system was operating within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183553-2017-00001 |
| MDR Report Key | 6234046 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-01-09 |
| Date of Report | 2017-01-26 |
| Date of Event | 2016-11-16 |
| Date Mfgr Received | 2017-01-20 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2017-01-09 |
| 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 | SIGNA PETMR |
| Generic Name | TOMOGRAPHIC IMAGER COMBINING EMISS |
| Product Code | OUO |
| Date Received | 2017-01-09 |
| Model Number | SIGNA PETMR |
| 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 | 2017-01-09 |