MEERA EU WITHOUT AUTO DRIVE 720001B0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for MEERA EU WITHOUT AUTO DRIVE 720001B0 manufactured by Holger Ullrich.

Event Text Entries

[181807635] 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 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


[181807636] 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


MAUDE Entry Details

Report Number3013876692-2020-00010
MDR Report Key9769067
Date Received2020-02-28
Date of Report2020-02-28
Date of Event2020-01-28
Date Facility Aware2020-01-31
Report Date2020-02-28
Date Reported to FDA2020-02-28
Date Reported to Mfgr2020-02-28
Device Manufacturer Date2017-04-11
Date Added to Maude2020-02-28
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer StreetMAQUET GMBH KEHLER STRASSE 31,
Manufacturer CityRASTATT 76437
Manufacturer CountryGM
Manufacturer Postal76437
Manufacturer G1HOLGER ULLRICH
Manufacturer StreetMAQUET GMBH KEHLER STRASSE 31,
Manufacturer CityRASTATT 76437
Manufacturer CountryGM
Manufacturer Postal Code76437
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEERA EU WITHOUT AUTO DRIVE
Generic NameTABLE, OPERATING-ROOM, AC-POWERED
Product CodeFQO
Date Received2020-02-28
Model Number720001B0
Catalog Number720001B0
Lot NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age34 MO
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHOLGER ULLRICH
Manufacturer AddressMAQUET GMBH KEHLER STRASSE 31, RASTATT 76437 GM 76437


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-28

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