MAUDE Adverse Event Report: KEHLER STRASSE 31 MAQUET EXTENSION DEVICE; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number 1419.01HC

Device Problem Component Falling (1105)

Patient Problem Fall (1848)

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturer is awaiting the return of the device in order to perform further investigations.A follow-up report will be submitted once additional information is available.(b)(4).Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

Customer reported that during a surgery the extension device was disengaged from the adapter and it fell down, and the patient also fell down from the table.The surgery was suspended but after reassemble the extension device to the adapter the surgery was completed with no problem.No serious injury reported.

Manufacturer Narrative

(b)(4).During investigation no product failure was detected.A technical manager from maquet visited the hospital and was able to confirm how the incident occurred.The hospital did not use the support bar.The doctor moved the patients' legs up and down widely and the device was overloaded.This caused the extension device disengage from the adapter.Maquet (b)(4) provides product failure investigation, analysis, and resolution for the device described in this report.Manufacturer reference # : (b)(4).

Event Description

Manufacturer reference # : (b)(4).

• Brand Name: MAQUET EXTENSION DEVICE
• Type of Device: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• 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: 5729542
• MDR Text Key: 48411697
• Report Number: 8010652-2016-00008
• Device Sequence Number: 1
• Product Code: FWZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1419.01HC
• Device Catalogue Number: 1419.01HC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2009
• 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