MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2015-07-24 for 3.0T PET/MR manufactured by Ge Medical Systems, Llc.
[16494239]
A field service engineer reported that they had been experiencing ringing in their ears due to exposure to loud noises from an mr unit during installation. The fe was evaluated by an ent physician who confirmed they have new hearing impairment.
Patient Sequence No: 1, Text Type: D, B5
[16757318]
Product code is ouo. (b)(6). Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[31697842]
The investigation revealed that the incident occurred on (b)(6) 2015 instead of 04/23/2015; a field engineer (fe) suffered hearing damage during installation of a 3t pet/mr system. The complaint was raised after the fe had been in the scan room, troubleshooting issues with the as-shipped hardware. Two issues contributed: 1. The fe was not wearing prescribed hearing protection & 2. The gradient coil was defective. Hearing protection requirements are documented & the fe had completed appropriate safety training. The elevated acoustic noise level was isolated to gradient coil failures. A compound effect of site conditions (cold temperatures, wedge locations, high shim mass) may have contributed to the failure. A review of complaints for all dv systems did not identify any other cases with this failure mode. Acoustic noise measurement survey was performed on 16 ge healthcare mr systems installed at customer sites. The results confirmed that they all met osha levels & are within specification. The root cause for this incident was service processes not followed, improper hearing protection. Management reinforced with the requirements for hearing protection with the field engineer. No further actions are planned at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183553-2015-00017 |
| MDR Report Key | 4940016 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2015-07-24 |
| Date of Report | 2015-04-23 |
| Date of Event | 2015-04-09 |
| Date Mfgr Received | 2015-10-22 |
| Device Manufacturer Date | 2015-02-04 |
| Date Added to Maude | 2015-07-24 |
| 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 EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRAD WHEELER |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD., W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625443347 |
| Manufacturer G1 | GE MEDICAL SYSTEMS, LLC |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53188 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.0T PET/MR |
| Generic Name | TOMOGRAPHIC IMAGER COMBINING EMISSION COMPUTED TOMOGRAPHY WITH NUCLEAR MAGNETIC |
| Product Code | OUO |
| Date Received | 2015-07-24 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2015-07-24 |