MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-21 for MAQUET MODUTEC SU8907040009 manufactured by Helena Lu.
[131491080]
After receiving this complaint, a maquet surgical workflows account manager spoke with customer, it's confirmed that: hospital staff normally transfer the iv pole to the m-shift trolley without any issue in the past. Hospital staff was trained , but have no training records. Maquet suzhou conducted following initial investigation after receiving the complaint. This concerned m-shift clamp was delivered in apr-y2017. Dhr and relevant record of this concerned m-shift clamp were reviewed, no any deviation was identified from the manufacturing process and final release testing. Complaint historic data about this concerned m-shift clamp were reviewed. There was no any feedback received during installation and after released to end user until dec-2018. Complaint historic data was also reviewed for any similar case reported in the past. Around (b)(4) units m-shift clamp have been configurated with csus and delivered since year 2015. Till now no similar case was reported. Maquet suzhou has sent an new m-shift clamp to customer for replacement, and is requesting the defectives sample back for further investigation. A follow-up report will be submitted when it is done. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131491081]
On (b)(6) 2018, hospital staff told maquet us when transfer the iv pole from ceiling supply unit to the m-shift trolley, as m-shift clamp did not engage onto the trolley, the iv pole and locking mechanism fell to the floor. No person was hit. No injury or death was reported. Manufacturer reference: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007417753-2018-00001 |
| MDR Report Key | 8191636 |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-11-28 |
| Date Mfgr Received | 2018-11-30 |
| Device Manufacturer Date | 2017-04-01 |
| Date Added to Maude | 2018-12-21 |
| 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 | 2018-12-21 |
| Model Number | MODUTEC |
| Catalog Number | SU8907040009 |
| Lot Number | 7010004530 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2018-12-21 |