MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CONNECTED OR MOUNT; CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)

Catalog Number 0240099158

Device Problems Difficult or Delayed Positioning (1157); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2022

Event Type  malfunction  

Event Description

It was reported that the arm of cart was drifting.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that the arm of cart was drifting.

Manufacturer Narrative

The product was returned to tekna manufacturer for investigation and the reported failure mode was not confirmed.Alleged failure: "the tilter will consistently lose tension no matter how hard i tighten the screw." manufacturer investigation results: "evaluation: the tilter has 20 cast into it indicating it was made in 2020.This means that the tilter has the new black zinc coating.I mounted the tilter to an sv7 monitor on (b)(6).It was loose and tilted down completely.I tightened up the set screw and then was able to position the monitor in any position and it maintained its position.I cycled the tilter up and down probably 50 times and it is still working properly.I asked (b)(6) how fast it was loosening up for the user as it is functioning properly.On the morning of (b)(6) 2022, it was still holding its position." tekna manufacturer root cause: "conclusion: i cycled the tilter up and down probably 50 times and it is still working properly." the reported failure mode will be monitored for future re occurrence.Manufacture date is not known.

• Brand Name: CONNECTED OR MOUNT
• Type of Device: CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13966228
• MDR Text Key: 294482550
• Report Number: 0002936485-2022-00151
• Device Sequence Number: 1
• Product Code: BZN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

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: 0240099158
• Device Lot Number: 2021AN00370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 02/18/2022
• Supplement Dates FDA Received: 05/04/2022
• 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