MAUDE Adverse Event Report: HOLGER ULLRICH ALPHASTAR MOBILE OPERATING TABLE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 113211B2

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problems Fall (1848); Tissue Damage (2104); Injury (2348)

Event Date 12/14/2018

Event Type  Injury  

Manufacturer Narrative

At the time of this report the investigating was still ongoing.As soon as the investigation is finished the report will be updated and a follow up/final report will be provided to fda.(b)(4).

Event Description

It was reported that a head extension came off the table with the patient on the table.The customer reported that the patient fell but was not hurt.We requested further information from the customer but it was not provided till the date of this report.Manufacturer reference # (b)(4).

Event Description

It was reported that a head extension came off the table with the patient on the table.The customer initially reported that the patient fell but was not hurt.We requested further information from the customer.On the follow up the customer informed us that there was a rotator cuff tear that required further surgery.Manufacturer reference#: (b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet gmbh, kehler strasse 31, rastatt, germany 76437.Exemption#: e2018004.Getinge usa sales, llc 45 barbour pond drive wayne, nj 07470.Contact person: (b)(4).Initially no patient injury was reported regarding this case.Ater requesting further information concerning this case, the customer informed us that a rotator cuff tear occurred due to this issue.This injury needs another surgery to be treated.At the time of this report the investigation was still ongoing.As soon as the investigation is finished the report will be updated and a follow up / final report will be provided to fda.

Manufacturer Narrative

It was reported that the head extension came off the table.We assume that a head rest or a head rest adapter was meant by "head extension".A head rest can be mounted to the table.We have requested further information concerning this case several times, but not received further details concerning this case.The table is not repaired by getinge-maquet, but a third party contractor.We assume that this issue was caused by one or a combination of the following causes: the head rest was not correctly mounted or loosened, the head rest interface was damaged due to overload or the head rest interface was used despite being damaged prior to use.The head rest has two pins which are inserted into corresponding holes at the table.Afterwards it is fixed by tightening two screws and it has to be checked that the head rest is mounted properly.This is described in the instructions for use (ifu).The user is warned concerning the risks related to not properly mounted accessories in the ifu: " risk of injury! accessories which are improperly mounted may come loose and cause injuries.Use maquet accessories exclusively and be sure to affix them correctly." the user is advised in the ifu to check the product prior to use: "for correct operation it is necessary to have visual and functional inspections performed by a trained person each time before using the operating table, at least once a day." the user is warned concerning the risks related to using damaged devices: "risk of injury! maquet products may be used only when properly lubricated and fully functional.Lubricate maquet products at regular intervals.Check to ensure that this maquet product is fully functional and in good working order prior to use." the permissable loads are provided in the ifu and the user is warned concerning the risk related to overload: "risk of injury due to material break or tipping over of the operating table! the accessories attached to the operating table must not exceed the maximum load (maximum distance to the accessory mounting point of the operating table).Accessory can be used without restriction within the permitted load of the operating table with its share of the load imposed by a patient weighing 135 kg.For a patient weight of up to 270 kg, the operating table and all accessories used must be approved for the respective patient weight in addition to the permitted load.Always take into account the maximum load, patient weight, accessories used as well as possible restrictions for adjustment." the production records of the device was checked and no irregularities were found.The history of this device was checked and no other complaints were reported.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.H3 other text : device not available.

Event Description

Manufacturer reference #: (b)(4).

• Brand Name: ALPHASTAR MOBILE OPERATING TABLE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 8357921
• MDR Text Key: 137046495
• Report Number: 8010652-2019-00006
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 113211B2
• Device Catalogue Number: 113211B2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention