MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BED INTOUCH WITH ZOOM MOTOR; STRETCHER, WHEELED

Catalog Number 2141000000

Device Problem Unintended System Motion (1430)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.2 devices were not evaluated, as the issue was identified and resolved during a troubleshooting call between the customer and stryker technical support.11 devices were evaluated in the field and the issue was confirmed; 10 devices had broken/damaged components and 1 device had a pinched/kinked cable.The devices were repaired and returned.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 13 malfunction event(s), where it was reported the device had unintended system motion.There was no patient involvement.

• Brand Name: BED INTOUCH WITH ZOOM MOTOR
• Type of Device: STRETCHER, WHEELED
• 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: 9237969
• MDR Text Key: 174720569
• Report Number: 0001831750-2019-01042
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327169232
• UDI-Public: 07613327169232
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113598
• Number of Events Reported: 13
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2141000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/01/2019
• 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