MAUDE Adverse Event Report: TIDI PRODUCTS LLC SAFETY VEST; RESTRAINT, PROTECTIVE

Model Number	3060M
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: customer confirmed product will not be returning for evaluation.Therefore, this event is reported solely on the information provided by the customer.Customer did not indicate any patient injuries due to the unclipping of the vest.Without the return of the device the reported issue could not be confirmed and without the device lot information the release documentation could not be confirmed.A review of the complaint database revealed two other complaints in the past 2 years where the patient was able to unclip the buckles.Both complaint were received from the same care facility, and in both cases, product was not returned for evaluation but staff were able to find a work around.It was noted if you loop the female end of the buckle through the same loop that it is connected to, (although very difficult), it keeps the buckle tucked further under the bed.The instructions for use (ifu) were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.Ifu states always monitor patient per facility policy.Improper application or use of any restraint may result in serious injury or death.Make sure straps cannot slide, loosen, or tighten if the patient pulls on them, or if the bed or chair seat position is adjusted.The patient may suffocate if the straps tighten.If the straps loosen, serious injury or death may occur from: patient escape; or from chest compression or suffocation if the patient becomes suspended in the restraint.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warrant.Manufacturer reference file (b)(4).
Event or Problem Description
Customer reporting a complaint on product 3060.(b)(6).Customer states that patients can undo the straps and clip on the 3060 vest.The patient then is able to get out of bed unsupervised.It is noted that product is not available for return for eval.

• Brand Name: SAFETY VEST
• Common Device Name: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 20871116
• Report Number: 2182318-2024-00167
• Device Sequence Number: 8574526
• Product Code: FMQ
• UDI-Device Identifier: 10190676002600
• UDI-Public: 10190676002600
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2024

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: 3060M
• Device Catalogue Number: 3060M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown