MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BED INTOUCH WITH ZOOM MOTOR; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 2141

Device Problem Intermittent Loss of Power (4016)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.48 devices were evaluated in the field and the issue was confirmed; 39 devices had worn components, 1 device had an incorrect/incompatible component, 9 devices had broken/damaged components, and 1 device had a detached component.The devices were repaired and returned.1 device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 49 malfunction events, where it was reported the zoom disengaged during use.There was 1 event where a user experienced pain.

• Brand Name: BED INTOUCH WITH ZOOM MOTOR
• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 10733659
• MDR Text Key: 213002839
• Report Number: 0001831750-2020-00940
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327169232
• UDI-Public: 07613327169232
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 49
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2020

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: No Information
• Device Model Number: 2141
• Device Catalogue Number: 2141000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: No
• 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