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

Model Number 113211A2

Device Problems Leak/Splash (1354); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2015

Event Type  malfunction  

Manufacturer Narrative

New information were provided to maquet on 2016-07-07.Not all movement of the table were available and the operation time extended.After re-assessment of the new information maquet decide to report this case to the competent authorities.We assume that when working on the side rail or when removing and refitting the side rail the hydraulic hose was inadvertently and unknowingly damaged.The defective hydraulic hose is located exactly by one of the holes/thread were the side rail is fixed.Damage of the hydraulic hose during the assembly is unlikely since the product is in clinical use for over 10 years.Damage of the hydraulic hose during maintenance is also unlikely since the last maintenance by maquet was carried out almost two years before the complaint.It is not clear when and by whom the damage of the hydraulic hose was caused.The defective hydraulic hose was changed by maquet service technician.This is a single case.Maquet does not have any information about similar cases.Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

The customer reported that during surgery the hydraulic pressure was lost.Oil was coming out from the table.The patient was not injured.(b)(4).

• Brand Name: MAQUET, MOBILE OR TABLE ALPHASTAR
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): KEHLER STRASSE 31; rastatt 76437 ; GM 76437
• Manufacturer (Section G): KEHLER STRASSE 31; rastatt 76437 ; GM 76437

rastatt 76437

• MDR Report Key: 5841295
• MDR Text Key: 52169648
• Report Number: 8010652-2016-00010
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 113211A2
• Device Catalogue Number: 113211A2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2005
• 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