MAUDE Adverse Event Report: HOLGER ULLRICH ALPHAMAX (460 MM LONGIT. SHIFT), EU; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 113322F5

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).After the incident the patient complained of pain in her neck.The patient's neck was examined but no injury as found.The patient received physiotherapy afterwards.In the mean time the patient reported that she was no longer in pain.The table was examined by the clinic after the incident.No defect was detected.A getinge-maquet service technician was on site and investigated the product in question.No defect was detected.Therefore we conclude the head plate was not correctly locked and came loose during the procedure.The clinic re-trained their staff in this matter.Getinge-maquet gmbh provides failure investigation, analysis and resolution for the device described in this report,.

Event Description

During a procedure under epidural anesthesia, the patient was lifting her head from the bed.The head section of the bed unexpectedly detached from the main section and fell to the floor leaving the patient's head unsupported.The section was reattached as quickly as possible but the patient is now complaining of a sore neck.Mfg reference # (b)(4).

• Brand Name: ALPHAMAX (460 MM LONGIT. SHIFT), EU
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer (Section G): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet gmbh; kehler strasse 31,; rastatt 76437
• MDR Report Key: 7944385
• MDR Text Key: 123519668
• Report Number: 8010652-2018-00024
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 113322F5
• Device Catalogue Number: 113322F5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2018
• 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): Other