MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6507 POWER PRO 2, HIGH CONFIG; STRETCHER, WHEELED

Model Number 650705550001

Device Problem Positioning Failure (1158)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

This report summarizes 17 malfunction events, where it was reported the devices experienced cot height cannot be adjusted.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.4 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.13 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Manufacturer Narrative

An additional event was identified and therefore added to this summary report.

Event Description

This report summarizes 19 malfunction events, where it was reported the devices experienced cot height cannot be adjusted.There was no patient involvement.

Event Description

This report summarizes 17 malfunction events, where it was reported the devices experienced cot height cannot be adjusted.There was no patient involvement.

Manufacturer Narrative

One device that was pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Section h codes have been updated to reflect this.

Manufacturer Narrative

(b)(4) devices that were pending evaluation were evaluated in the field and the issue was confirmed.The devices were repaired on site and returned to service.(b)(4) pending device was not evaluated, as the issue was identified and resolved through communication/interviews with the user facility; no defect or malfunction was found.(b)(4) devices that were pending were evaluated and it was determined the device experienced difficult to raise/lower, which is not reportable.Section h codes have been updated.Because of this, the number of reported events has been changed from (b)(4).

Event Description

This report summarizes (b)(4) malfunction events, where it was reported the devices experienced cot height cannot be adjusted.There were (b)(4) events with patient involvement; no adverse consequences were reported.

Manufacturer Narrative

An additional event was identified and therefore added to this summary report.

Event Description

This report summarizes 18 malfunction events, where it was reported the devices experienced cot height cannot be adjusted.There was no patient involvement.

Event Description

This report summarizes 17 malfunction events, where it was reported the devices experienced cot height cannot be adjusted.There was no patient involvement.

Manufacturer Narrative

1 device that was pending was evaluated and it was determined the device experienced difficult to raise/lower which is not reportable.1 device that was pending was found to be a duplicate of another record.Because of this, the number of reported events has been changed from 19 to 17.1 device pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.

Manufacturer Narrative

1 device that was pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.8 devices are still pending evaluation.

Event Description

This report summarizes 17 malfunction events, where it was reported the devices experienced cot height cannot be adjusted.There was no patient involvement.

Event Description

This report summarizes 14 malfunction events, where it was reported the devices experienced cot height cannot be adjusted.There were 5 events with patient involvement; no adverse consequences were reported.

Manufacturer Narrative

One of the devices that was originally evaluated was determined that the device experienced cot difficult to raise/lower, which is not reportable.Because of this, the number of reported events has been changed from 15 to 14.

• Brand Name: 6507 POWER PRO 2, HIGH CONFIG
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16806357
• MDR Text Key: 313911828
• Report Number: 0001831750-2023-00438
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 14
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/19/2023

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 Model Number: 650705550001
• Device Catalogue Number: 650705550001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 04/01/2023; 04/01/2023; 04/01/2023; 04/01/2023; 04/01/2023; 04/01/2023; 04/01/2023
• Supplement Dates FDA Received: 04/28/2023; 04/28/2023; 05/02/2023; 05/09/2023; 07/24/2023; 09/12/2023; 09/19/2023
• 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