MAUDE Adverse Event Report: KEHLER STRASSE 31 MAQUET ALPHAMAXX; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 1133.02B2

Device Problems Mechanical Problem (1384); Positioning Problem (3009)

Patient Problem Dyspnea (1816)

Event Date 12/08/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A maquet field service technician (fst) visited the hospital and checked the table.The hospital staff told him that one of the two batteries had been defective.The table was already repaired by the hospital staff.A detailed investigation by maquet thus was no longer possible.The functions and all movements have been tested several times.No error was found.The mobile operating table alphamaxx has two built-in batteries.To charge the batteries the operating room table may also be connected by means of a power cord to the mains voltage.As a result, the table can be operated by battery or mains.Thus, the table remains functional even with defective batteries.Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

The hospital reported that during a spinal anesthesia, the operating room table could no longer be moved and change in the position of the table top (e.G.Tilting) was not possible either.This led to increase in the spinal anesthesia to cervical and impaired breathing of the patient.Finally, the patient had (120 kg) to be manually taken to another table so that the section could take place.No further consequences reported to maquet.(b)(4).

• Brand Name: MAQUET ALPHAMAXX
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): KEHLER STRASSE 31; rastatt 76437 ; GM 76437
• Manufacturer (Section G): MR. BERND RAKO; maquet gmbh; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet gmbh; kehler strasse 31; rastatt 76437
• MDR Report Key: 5318251
• MDR Text Key: 34807965
• Report Number: 8010652-2015-01010
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1133.02B2
• Device Catalogue Number: 1133.02B2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• 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): Required Intervention