MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BED INTOUCH WITHOUT ZOOM MOTOR; BED, AC POWERED ADJUSTABLE

Catalog Number 2131000000

Device Problem Incorrect Measurement (1383)

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

Event Date 04/01/2023

Event Type  malfunction  

Event Description

This report summarizes 1 malfunction event, where it was reported the device experienced inaccurate scale readings.There was no patient involvement.

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was functionally/visually inspected in the field.The device was repaired and returned to use.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 0 malfunction event, where it was reported the device experienced inaccurate scale readings.There was no patient involvement.

Manufacturer Narrative

It was originally reported that the scale was inaccurate.It was found that this was reported in error and the device was evaluated under a different wo where it was reported that there was no electric function, which is not reportable.Section h codes have been updated.Because of this, the number of reported events has been changed from 1 to 0.

• Brand Name: BED INTOUCH WITHOUT ZOOM MOTOR
• Type of Device: BED, AC POWERED ADJUSTABLE
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18291896
• MDR Text Key: 330053483
• Report Number: 0001831750-2023-00739
• 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): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 2131000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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