MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS FLAT PANEL SPRING ARM, ONDAL SUSP., 12-18KG

Catalog Number 0682000212

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the flat panel was damaged and needed to be replaced.During the onsite investigation the field service technician (fst) found that a boom arm was lowered onto a yoke and monitor.The monitor twisted to its end stops and became damaged.It is suspected that force was continually applied and this translated to the rest of the system, including the spring arm.This force caused the spring arm c-clip to move out of place and become ineffective.With the c-clip ineffective, the spring arm had the capability to disengage.The fst replaced the spring arm and the unit has been returned to use.There was no patient involvement or adverse consequence reported.

Event Description

It was reported that in or 6 the flat panel spring arm is damaged and needs to be replaced (eds suspension).There was no patient involvement or adverse consequence reported.

• Brand Name: FLAT PANEL SPRING ARM, ONDAL SUSP., 12-18KG
• Type of Device: FLAT PANEL SPRING ARM
• Manufacturer (Section D): STRYKER-COMMUNICATIONS; 1410 lakeside parkway #100; flower mound TX 75028
• Manufacturer (Section G): STRYKER-COMMUNICATIONS; 1410 lakeside parkway #100; flower mound TX 75028
• Manufacturer Contact: jenny harris ; 1410 lakeside parkway #100; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 7168905
• MDR Text Key: 96618107
• Report Number: 0002031963-2018-00001
• 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: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0682000212
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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