MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,05,07 report with the FDA on 2014-01-09 for MAQUET MODUTEC NA manufactured by Maquet Suzhou Co. Ltd.
[4194793]
It was reported to maquet (b)(4) that a plastic, axis #2 motor cover detached from a modutec power pendant and fell onto a nurse. No injury or other adverse consequences occurred. No patient was involved in this incident. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11629936]
A maquet (b)(4) fse (field service engineer) visited the hospital and evaluated the device. He found the fallen cover had no damage but the three nylon screws used to secure the cover to the device had broken. The fse in charge of the initial installation verified that all covers and screws were examined prior to the release of the operating room to the customer; everything was in place and there were no issues at that time. A review of the design of the cover was made, and mechanical evaluation testing was performed. No issues were found. During the investigation maquet observed a c-arm and other medical devices in close proximity to ceiling pendant, maquet believes the rot issue to be a failure of the operating room staff to be aware of their surrounding when positioning the other devices, and suspects one of these devices collided with the pendant, breaking the fastening screws. The fse replaced the screws to secure the cover during the visit and maquet has advised the customer to avoid collisions to ensure safe operation. Maquet medical systems usa submits this report on behalf of the device manufacturing facility. Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007417753-2014-00001 |
| MDR Report Key | 3647616 |
| Report Source | 01,04,05,07 |
| Date Received | 2014-01-09 |
| Date of Report | 2013-12-19 |
| Date of Event | 2013-12-18 |
| Date Facility Aware | 2013-12-19 |
| Report Date | 2014-01-10 |
| Date Mfgr Received | 2013-12-19 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2014-05-19 |
| 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 | MS. JANICE PEVIDE |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097753 |
| Manufacturer G1 | MAQUET SUZHOU COMPANY LTD |
| Manufacturer Street | NO.158 FANG ZHOU ROAD SUZHOU INDUSTRIAL PARK |
| Manufacturer City | SUZHOU 215024 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215024 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAQUET |
| Product Code | FQP |
| Date Received | 2014-01-09 |
| Model Number | MODUTEC |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET SUZHOU CO. LTD |
| Manufacturer Address | SUZHOU CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-09 |