MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CONNECTED OR CART, 120 V; CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)

Model Number 240099155

Device Problems Nonstandard Device (1420); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2019

Event Type  malfunction  

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

Alleged failure: "cart monitor arm drifting (horizontal left/right drift at the first arm closest to the top of the cart, not drooping)" probable root cause: the reported horizontal arm drift was caused by a missing friction-adjust screw.This is a manufacturer defect (nc#2136649 assigned) the product was not returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future re occurrence.Manufacture date is not known.

Event Description

It was reported that the arm of cart was drifting.

• Brand Name: CONNECTED OR CART, 120 V
• Type of Device: CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8760684
• MDR Text Key: 150126658
• Report Number: 0002936485-2019-00281
• Device Sequence Number: 1
• Product Code: BZN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

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: Other
• Device Model Number: 240099155
• Device Catalogue Number: 0240099155
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 06/14/2019
• Supplement Dates FDA Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1