MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC TROLLEY, PAGEWRITER TC70

Model Number 860318

Device Problem Defective Component (2292)

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

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported bottom bracket that hold the wheels to the trolly chassis is broken.The device was not in use on a patient at the time of event, there was no patient involvement.

Event Description

The customer reported the bottom bracket that hold the wheels to the trolley chassis is broken and the shipping box was not damaged.The device was not in use on a patient at the time of event, there was no patient involvement.

Manufacturer Narrative

H3 other text : customer didn't return product.

• Brand Name: TROLLEY, PAGEWRITER TC70
• Type of Device: TROLLEY, PAGEWRITER TC70
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12944226
• MDR Text Key: 281918236
• Report Number: 1218950-2021-11159
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00884838026582
• UDI-Public: 00884838026582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 860318
• Device Catalogue Number: 860318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/06/2021
• 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