MAUDE Adverse Event Report: ARJO INC.; BED, PATIENT ROTATION, POWERED

Device Problem Device Inoperable (1663)

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

Event Date 12/01/2017

Event Type  malfunction  

Event Description

The crank on the rotoprone bed malfunctioned, which made it difficult to secure the patient in for rotoprone therapy.

• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJO INC.; 12625 wetmore rd ste 308; san antonio TX 78247
• MDR Report Key: 7206083
• MDR Text Key: 97885647
• Report Number: 7206083
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2017,01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1