MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PERFORMANCE PRO AMBULANCE COT; STRETCHER, WHEELED

Catalog Number	6086000000
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer that two midwives, both slight in build, were placing the patient onto the cot and attempting to raise the cot back up to the height of a bed for the patient to be readmitted to the maternity bed.However in doing so, it was alleged the two midwives sustained back injuries due to the manual handling nature of the cot and the fact the patient was on the cot at the time.The staff were unable to raise the cot from the lowered position to allow for transport of the patient back to the ward bed.The patient was not injured during this event.
Additional Manufacturer Narrative
A visual and functional inspection was performed.It was identified that there were no defects that would have caused or contributed to the cot allegedly not reaching load height.This issue was resolved for the customer by functionally inspecting the cot before returning to service.It was stated that further injury information regarding treatment for the two injured midwives could not be provided.
Event or Problem Description
It was reported by the customer that two midwives, both slight in build, were placing the patient onto the cot and attempting to raise the cot back up to the height of a bed for the patient to be readmitted to the maternity bed.However in doing so, it was alleged the two midwives sustained back injuries due to the manual handling nature of the cot and the fact the patient was on the cot at the time.The staff were unable to raise the cot from the lowered position to allow for transport of the patient back to the ward bed.The patient was not injured during this event.

• Brand Name: PERFORMANCE PRO AMBULANCE COT
• Common Device Name: STRETCHER, WHEELED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 8785405
• Report Number: 0001831750-2019-00607
• Device Sequence Number: 13962664
• Product Code: FPO
• UDI-Device Identifier: 07613327261554
• UDI-Public: 07613327261554
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 6086000000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1