MAUDE Adverse Event Report: ALLEN MEDICAL SYSTEMS CHEST SUPPORT WITH PAD; TABLE AND ATTACHMENTS, OPERATING-ROOM

Catalog Number A-71301

Device Problem Break (1069)

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

Event Date 01/02/2020

Event Type  malfunction  

Event Description

Chest pad broke during surgery.

• Brand Name: CHEST SUPPORT WITH PAD
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): ALLEN MEDICAL SYSTEMS; 100 discovery way; acton MA 01720
• MDR Report Key: 9590524
• MDR Text Key: 175033119
• Report Number: 9590524
• Device Sequence Number: 1
• Product Code: BWN
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: A-71301
• 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: 01/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18980 DA