MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-22 for MAQUET MODUTEC manufactured by Helena Lu.
[75857722]
The initial investigation has been done together with field service engineer as following. - customer stated that the end beam cover fell off after being hit, rather than a normal use. As checked, this unit was manufactured and delivered in year 2009, and there was no any feedback received regarding this unit in the past years, therefore we could believe it? S in a normal condition as intended until this issue happened. - as review of the complaint history, there are a few similar cases happened since launch of this product modutec. Refer to the investigation results, these reported cases are all caused by hitting/collision with other equipment during positioning the device which are concluded as use error since the design of the end cover is demonstrated compliance with iec 60601-1 by design verification, and additionally a warning is included in user manual to remind the customer to avoid collision when moving devices. With the above information, we can indicate this complaint case is also very likely caused by use error- careless during positioning of the device which resulting in the hitting between devices. Customer decided to order a spare part of end cover to fix the issue. Maquet field service engineer is scheduling a visit with customer to seek more information and provide the support for fixing the issue. A follow-up report will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[75857723]
On (b)(6) 2017, a hospital in usa reported that the beam end cover of the modutec fell off after being hit. No injury was reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[77548891]
According to further communication with the customer, it is specified that: the beam end cover was hit by the surgical light when they moved the surgical light close to the bed. That is the reason which made the beam end cover be loose and fall off finally. With above information, it proves that this complaint was caused by use error- careless during positioning of the device which resulting in the hitting between devices.
Patient Sequence No: 1, Text Type: N, H10
[77548892]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007417753-2017-00002 |
| MDR Report Key | 6581370 |
| Date Received | 2017-05-22 |
| Date of Report | 2017-06-14 |
| Date of Event | 2017-04-27 |
| Date Mfgr Received | 2017-04-27 |
| Device Manufacturer Date | 2009-11-14 |
| Date Added to Maude | 2017-05-22 |
| 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 | 3 |
| Brand Name | MAQUET |
| Generic Name | TUBING, PRESSURE AND ACCESSORIES |
| Product Code | BYX |
| Date Received | 2017-05-22 |
| Model Number | MODUTEC |
| 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 | 2017-05-22 |