MAUDE Adverse Event Report: MAQUET GMBH AND CO. KG MAQUET, MOBILE OPERATING TABLE ALPHAMAXX; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 1133.22B1

Device Problems Circuit Failure (1089); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Pneumonia (2011)

Event Date 03/20/2014

Event Type  Injury  

Event Description

During a procedure with the pt intubated, the patient refluxed and stomach acid came up into the tube.The operating nurse attempted to move the maquet operating table into trendelenburg position to avoid acid in the patient's lungs.The table did not respond to the hand control and an error code was displayed on the had control unit.After an extended delay, the operating room staff was able to reposition the table, using the override control panel built into the table.The pt was diagnosed with pneumonia after this event.Mfr reference #(b)(4).

Manufacturer Narrative

A maquet field service tech (fst) investigated the device and found a defective sensor.As result of this malfunction, control of the table via hand control was not possible.The alphamaxx or table is equipped with an override panel integrated into the column of the table.This panel supersedes any external control device and per the instructions for use ((b)(4)) is to be used if the table fails to respond to the commands of the hand control unit.Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: MAQUET, MOBILE OPERATING TABLE ALPHAMAXX
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH AND CO. KG; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH AND CO. KG; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: janice pevide ; 45 barbour road pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3766624
• MDR Text Key: 4377555
• Report Number: 8010652-2014-00010
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/14/2014,03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1133.22B1
• Device Catalogue Number: 1133.22B1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/09/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization