MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-03 for MEERA EU WITHOUT AUTO DRIVE 720001B0 manufactured by Maquet Gmbh.
[188643907]
The affected or table can be operated by using the following control devices: corded control device, ir remote control, foot switch or override control panel. The override control panel is for emergency operation. If there are any malfunctions or if the control device is defective, then the mobile operating table can be controlled using the override control panel. The collision warning function is not active if the table is operated via the override control panel. The user is advised in the ifu concerning the use of this panel as follows: "[... ] when operating the or table using the override control panel, the collision warning function is not active. Watch every adjustment carefully and avoid collisions, especially when implementing extreme inclination and lateral tilt settings. " a getinge-maquet representative who was in contact with the customer has stated that the table was operated via the override control panel when this issue occurred. The back plate collided with a part of the column and broke. Therefore we assume a use error as most probable root cause for this issue. A getinge-maquet representative has contacted the customer and offered further training for the staff of the affected hospital. The back plate consists among other parts of a hard paper plate that is covered by a pad. The pad is between the hard paper plate and the patient. The clinic confirmed that this pad was in place. A picture of the damaged hard paper plate was provided for a similar incident. The tear was affecting the edge of the plate. Most likely during patient transfer from the table, the patient received a scratch. Further details concerning this injury and its treatment were requested, but not provided. Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.
Patient Sequence No: 1, Text Type: N, H10
[188643908]
The following was reported. The column control panel was used to operate the or table during a surgery. The tables' back plate was lowered, hit the column and broke. Due to this issue the surgery was delayed and the patient received a superficial scratch. No serious injury was reported. We report this as adverse event in abundance of caution. Manufacturer reference# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013876692-2020-00014 |
| MDR Report Key | 9779442 |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date Facility Aware | 2020-03-03 |
| Report Date | 2020-03-03 |
| Date Reported to FDA | 2020-03-03 |
| Date Reported to Mfgr | 2020-03-03 |
| Device Manufacturer Date | 2019-03-15 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEERA EU WITHOUT AUTO DRIVE |
| Generic Name | TABLE, OPERATING-ROOM, AC-POWERED |
| Product Code | FQO |
| Date Received | 2020-03-03 |
| Model Number | 720001B0 |
| Catalog Number | 720001B0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET GMBH |
| Manufacturer Address | KEHLER STRASSE 31 RASTATT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-03 |