MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO S3 SIGNATURE OBS 01/13; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 3002S3SIGNATURE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2016

Event Type  malfunction  

Event Description

It was reported by service report that the fowler displayed phantom motion.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: S3 SIGNATURE OBS 01/13
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8744675
• MDR Text Key: 149655545
• Report Number: 0001831750-2019-00598
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3002S3SIGNATURE
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2010
• 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