MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-14 for MAQUET manufactured by Helena Lu.
[73023465]
A company field service engineer visited the hospital and evaluated the device. He was informed that the connecting screw inside the knob broke shortly after a patient monitor (about 5kg) was clamped on the knob. Maquet (b)(4) conducted the following initial investigation after receiving the complaint: - the knob and monitor arm are provided by our qualified supplier, delivered by maquet and installed on site with the maquet modutec device. The relevant records related to the broken knob were reviewed. No nonconformity was recorded before delivery, during unpacking and during installation. - the complaint data since year 2008 was reviewed. No similar failure was reported out of around (b)(4) itd knobs delivered. - the supplier reviewed the design history of this knob. This knob passed the vertical load test with an 8x safety factors (total 80kg) and the horizontal load test with a 6x safety factors (60kg) according to en 60601-1. It also passed the life-cycle test (10000 cycles) under maximum load, simulating 10 years of use. The design of the knob was therefore demonstrated to be sufficiently robust. The broken knob was replaced by a new one. No issue was reported by the hospital. The defective sample will be returned to the supplier for further analysis. A follow-up report will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[73023466]
On (b)(6) 2017, a hospital in (b)(6) reported that the knob used with the monitor arm broke and fell on the floor. No injury or death was reported. No similar complaint was reported so far. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007417753-2017-00001 |
| MDR Report Key | 6493239 |
| Date Received | 2017-04-14 |
| Date of Report | 2017-06-30 |
| Date of Event | 2017-03-21 |
| Date Mfgr Received | 2017-06-16 |
| Device Manufacturer Date | 2015-10-21 |
| Date Added to Maude | 2017-04-14 |
| 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 |
| 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 | 2017-04-14 |
| 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 | 2017-04-14 |