MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-19 for MAQUET MODUEVO(ENERGY) manufactured by Helena Lu.
[145754916]
(b)(4). Maquet (b)(4) conducted following initial investigation after receiving the complaint. Dhr of this concerned ceiling supply unit(csu) was reviewed. This unit was produced in jun of 2018, the dhr showed no any deviation identified from the manufacturing process and final release testing. Complaint historic data was also reviewed for any similar case reported in the past. Around (b)(4) units moduevo energy have been delivered since year 2016. Till now no similar complaint were received. When adjust the height of energy by handle, the screw rod moves upward or downward. When we put the hose on the brass nut, we found that the hose would not fall off during the movement, when the brass nut and the bearing housing bite, the hose gets stuck inside. So according this, it is concluded the hose was pulled into the screw rod when energy moves, and the hole in the o? Hose was crushed when the brass nut bit the bearing housing. Maquet field service engineer cut the part with hole of the o2 hose, then re-connect the hose with a connector. Furthermore, the hoses were tied together with cable ties to make sure they will not be pulled into the screw rod when energy moves, to prevent the further damage. Maquet (b)(4) is collecting more detail information for further investigation, and the result will be provided in follow-up/final report.
Patient Sequence No: 1, Text Type: N, H10
[145754917]
This problem was occurred in (b)(6), but since the similar product are sold to us, so we also need to this report. On (b)(6) 2019, getinge (b)(4) gmbh received a complaint from one hospital in (b)(6) that during surgery, when moving a ceiling supply unit, a hissing noise was heard very quickly. The oxygen supply via the ceiling supply unit failed. The doctor establishes patient safety by immediately switching the o? Tube from the ceiling supply unit to the o? Wall supply. On the same day, field service technician's visited this hospital. He observed o? Hose was stuck between bearing housing and brass nut after he disassembled the cover of energy. Adjusting the energy and taking out the o? Hose, he also observed there is a hole in the o? Hose. It is obvious that a hissing noise is from the hole on the hose. No injury or death was reported. Manufacturer reference: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007417753-2019-00001 |
| MDR Report Key | 8531312 |
| Date Received | 2019-04-19 |
| Date of Report | 2019-08-26 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-03-21 |
| Device Manufacturer Date | 2018-06-26 |
| Date Added to Maude | 2019-04-19 |
| 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 |
| 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 |
| Remedial Action | RP |
| 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 | 2019-04-19 |
| Model Number | MODUEVO(ENERGY) |
| Lot Number | 7010007711 |
| 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 | 2019-04-19 |