MAUDE Adverse Event Report: MIZUHO MEDICAL CO., LTD SKYTRON; 3600B ULTRASLIDE BATTERY TABLE

Model Number 3600B

Device Problems Leak/Splash (1354); Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 03/23/2017

Event Type  Injury  

Event Description

(b)(6) of (b)(6) contacted technical services to advise of an event with patient involvement, no injuries were reported.Described as patient on the table, tilt left initiated resulting in a blown cylinder and jerky response from the table and subsequent major leakage of hydraulic fluid.Patient was restrained and table taken out of service.(b)(4) called (b)(6) on 3/23/2017 and interviewed (b)(6).On 3/24/2017 (b)(4) visited the site at 8am and interviewed manager of surgery, (b)(6).Video of the re-enactment is available.The table was inspected by a (b)(4) distributor and the table was placed into storage.A loaner table was ordered in from another facility and no delay in cases was experienced.Service records are not available for the table.(b)(4) complaint number (b)(4).(b)(4) created rma number (b)(4) for the return of the table to evaluated further.Table has since been returned to (b)(4) and is being evaluated.

• Brand Name: SKYTRON
• Type of Device: 3600B ULTRASLIDE BATTERY TABLE
• Manufacturer (Section D): MIZUHO MEDICAL CO., LTD; 2-27-17 hongo; byun-ku; tokyo, 113 ; JA 113
• MDR Report Key: 6521973
• MDR Text Key: 73708279
• Report Number: 1825014-2017-00001
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3600B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2017
• Distributor Facility Aware Date: 03/24/2017
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention