MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-27 for MAQUET MODUTEC manufactured by Helena Lu.
[78589563]
The investigation has been done together with maquet service us as following. - customer stated that the end beam cover fell off after being hit by other equipment in the room , rather than a normal use. As checked, this unit was manufactured and delivered in year 2015, and there was no any feedback regarding the end beam cover connection during installation or previous maintenance. Therefore, we could believe it? S in a normal condition as intended until this issue happened. - the design of the end beam cover is demonstrated compliance with (b)(4) by design verification, and additionally a warning is included in user manual to remind the customer to avoid collision when moving devices. Therefore, the design of the end beam cover was demonstrated robust for normal use. With the above information, we can indicate this complaint case is caused by use error- careless during positioning of the device which resulting in the hitting between devices. Maquet service us had replaced the broken end beam cover, adjusted the stops on the modutec and instructed the customer on the proper use of the modutec to help avoid collisions
Patient Sequence No: 1, Text Type: N, H10
[78589564]
On jun 08, 2017, the hospital staff told maquet service us that the beam end cover of the modutec fell off after being hit, and the exact event date was unknown. No injury was reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007417753-2017-00005 |
| MDR Report Key | 6669372 |
| Date Received | 2017-06-27 |
| Date of Report | 2017-06-27 |
| Date Mfgr Received | 2017-06-08 |
| Device Manufacturer Date | 2015-06-08 |
| Date Added to Maude | 2017-06-27 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | MAQUET (SUZHOU) CO., LTD NO.158, FANG ZHOU RD. SUZHOU |
| Manufacturer City | SUZHOU 215024 |
| Manufacturer Country | CH |
| Manufacturer Postal | 215024 |
| Manufacturer G1 | HELENA LU |
| Manufacturer Street | MAQUET (SUZHOU) CO., LTD NO.158, FANG ZHOU RD. SUZHOU |
| Manufacturer City | SUZHOU 215024 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MAQUET |
| Generic Name | TUBING, PRESSURE AND ACCESSORIES |
| Product Code | BYX |
| Date Received | 2017-06-27 |
| Model Number | MODUTEC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HELENA LU |
| Manufacturer Address | MAQUET (SUZHOU) CO., LTD NO.158, FANG ZHOU RD. SUZHOU SUZHOU 215024 CH 215024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-27 |