MAUDE Adverse Event Report: MAQUET SURGICAL SYSTEMS USA MEERA MOBILE OPERATING TABLE; SURGICAL TABLE

Catalog Number 7200.01F0

Device Problem Power Problem (3010)

Patient Problem No Code Available (3191)

Event Date 05/14/2018

Event Type  malfunction  

Event Description

Patient was on the table already put to sleep by anesthesiologist when the or table stopped working.Lockout tag showed the problem as: no power source.Manufacturer response for operating room table, (b)(6) (per site reporter): biomed already called company but as of report, said equipment is in or suite cysto a--still not fixed and not useable.

• Brand Name: MEERA MOBILE OPERATING TABLE
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): MAQUET SURGICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 7784111
• MDR Text Key: 117160128
• Report Number: 7784111
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7200.01F0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Weight: 91